LASIK NEWS

On October 03, 2013, Dr. Oz and Consumer expert Elisabeth Leamy took a hard look at LASIK Surgery’s Life-Altering Side Effects

LASIK surgery promises to fix imperfect eyesight, but is it safe? Investigative reporter and consumer expert Elisabeth Leamy went undercover to find out more about the potential life-changing side effects of this popular surgery.

http://www.doctoroz.com/article/hard-look-lasik-surgery

Watch the video! Take a hard look at Dr. Shulman who represents the American Society of Cataract and Refractive Surgery (ASCRS) – looks a little nervous…

Dr. Oz Show 10/03/2013 Investigates – A HARD LOOK AT LASIK!

ASCRS’s reponse to the show:

SOURCE

The American Society of Cataract and Refractive Surgery represents more than 9,000 eye surgeons worldwide. ASCRS treats all concerns about the safety and effectiveness of LASIK very seriously. Based on substantial research and data collected over decades, ASCRS is convinced that LASIK is safe and effective, and offers a viable option for dramatically improving the quality of life for millions of qualified candidates.

LASIK’s safety and effectiveness have been demonstrated in extensive studies conducted repeatedly over the past 20 years, involving thousands of patients and ever-improving technology. Multiple peer-reviewed studies published in medical journals show that more than 95 percent of LASIK patients are satisfied with their results. They also report that for the few patients who experience dry eye and night vision issues, the majority of their side effects resolve over time. Long-term LASIK side effects are extremely rare. ASCRS fully supports additional research to determine why side effects occur and how best to resolve them.

LASIK is surgery, and like all surgeries it involves some risk. In addition, not everyone is a good candidate for LASIK. People considering LASIK should research the procedure thoroughly, choose a qualified, board-certified surgeon, and discuss at length with the surgeon the risks and benefits of LASIK. Patients should work with their doctor to determine whether the procedure is right for them and their lifestyle. ASCRS and other organizations have resources available for anyone considering LASIK to assist in making an informed decision. To learn more about ASCRS please visit www.ASCRS.org.

In the opinion of the website’s original author, ASCRS was notified of this patients’ doctors violations of federal rules, regulations, and protocols prior to and during their investigational study. Such as the case for this and many other LASIK casulties, they did absolutely nothing to protect others damaged. ASCRS like the AAO, FDA, and states medical boards are simply “Those in the industry protecting their own!”.

Speaking of the FDA, some damaged LASIK patients would like to hear the FDA’s embellished biased response!

THE LAW OFFICES OF TODD J KROUNER & LASIK

Todd J. Krouner founded the Law Office of Todd J. Krouner in October 1994 and for nearly the past two decades has worked on a diverse range of plaintiffs’ litigation matters. In July 2005, he obtained a verdict of $7.25 million, which is the largest verdict ever for a case involving LASIK medical malpractice, Schiffer v. Speaker, et al.

To date, Mr. Krouner represents the best available resource for a positive legal outcome after a bad LASIK procedure. His knowledge and expertise is noted in many of the news stories on this page and throughout the internet for LASIK related lawsuits.

FARZAD YAGHOUTI and GLOBAL LASER VISION SUED FOR LASIK MALPRACTICE

Superior Court of California, County of San Diego, Civil Action No. 37-2016-00038327-CU-MM-CTL

On November 1, 2016, plaintiff Ashli Bryant filed suit against Farzad Yaghouti, M.D., and Global Laser Vision, in the Superior Court of California, County of San Diego, for the negligent performance of LASIK surgery.

The complaint alleges that on November 13, 2015, Dr. Yaghouti performed elective LASIK eye surgery on both of Ms. Bryant’s eyes.

The complaint further alleges that during the course of surgery on Ms. Bryant’s right eye, the treatment was interrupted. Instead of resuming the surgical treatment where it had been interrupted, Dr. Yaghouti caused or allowed the excimer laser to reinitiate the treatment from the beginning of the treatment plan, causing overtreatment of Ms. Bryant’s right cornea.

As a result of the elective LASIK surgery performed by Dr. Yaghouti, Ms. Bryant suffered severe, serious, and permanent injuries to her right cornea.

Ms. Bryant is represented by Todd J. Krouner of the Law Office of Todd J. Krouner in Chappaqua, New York, and Steven C. Vosseller of Law Office of Steven C. Vosseller, in San Diego, California. Mr. Krouner represents victims of LASIK surgery throughout theUnited States. Mr. Vosseller has extensive experience in litigating medical malpractice actions.

A copy of plaintiff’s complaint is available here. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Steven C. Vosseller, Esq., at (858) 429-4062

The Super Bowl: LASIK And Professional Athletes

Roman Harper is a safety for the Carolina Panthers.  In the NFC Championship game, a headshot left him temporarily blind in one eye, with his corneal flap from LASIK surgery dangling unhinged. He says his LASIK flap has been re-attached and he will be ready to play in the Super Bowl. Click here to read SB Nation’s article about the incident.

Mr. Harper is fortunate.  His experience serves a reminder that the corneal flap cut in LASIK never fully heals.  I ask victims of LASIK surgery what motivated them to assume the undisclosed 50% probability of dry eyes, diminished night vision, or light phenomenon like glare and halos.  Many say that they wanted LASIK to be free of glasses or contact lenses for sports activities.   But LASIK is contraindicated for head blows.  Boxers should not have LASIK.  Mr. Harper’s experience reminds us that LASIK is not a good idea for football players.  The same is probably true for soccer, rugby and hockey players, among others.

One last warning.  We rarely hear about bad LASIK outcomes for professional athletes (other than Mr. Harper’s).  It is not that they do not exist. Rather, professional athletes cannot complain. We know that from the NFL’s concussion experience.  First, players want to play.  Second, they do not want to risk their lucrative contracts by complaining about blurry vision or the glare and halos coming off of the bright stadium lights.

Whether you are an amateur or professional athlete, take note of Roman Harper’s vision threatening experience.  Think twice before trading contact lens for LASIK surgery.

DRS. ATWAL AND ZIMMERMAN SUED FOR LASIK SURGERY MALPRACTICE

Jacob Smith v. Amar Atwal, M.D., Jay S. Zimmerman, O.D., Amar Atwal, M.D., P.C., Atwal Eye Care and Buffalo Eye Care

In the Supreme Court of Erie County, State of New York, Case No. 813469/2015

On November 20, 2015, Jacob Smith filed a complaint against Amar Atwal, M.D., Jay S. Zimmerman, O.D., Amar Atwal, M.D., P.C., Atwal Eye Care and Buffalo Eye Care, in the Supreme Court of Erie County, State of New York, for medical malpractice arising from the performance of elective LASIK eye surgery, which the patient never should have had because of pre-existing corneal disease.

The complaint states that on May 30, 2013, Dr. Atwal performed elective LASIK eye surgery on both of Mr. Smith’s eyes. The complaint alleges that Dr. Atwal and Dr. Zimmerman, the optometrist, both screened Mr. Smith for, and recommended the elective LASIK eye surgery.  The complaint further alleges that Drs. Atwal and Zimmerman failed to recognize signs of corneal disease known as form fruste keratoconus, for which elective LASIK eye surgery is contraindicated.  As a result, Mr. Smith developed post-LASIK ectasia.

The complaint also alleges that to treat the post-LASIK ectasia, Mr. Smith is scheduled to undergo collagen cross linking surgery (“CXL”), in the hope of preserving whatever vision remains in his eyes. CXL is an experimental surgical procedure, which is not currently approved for use in the United States by the United States Food and Drug Administration.  If the CXL experimental procedure is not effective in saving Mr. Smith’s vision, he may have to undergo further vision-threatening cornea transplant surgery.

The complaint states that generally, individuals who are diagnosed with post-LASIK ectasia suffer from a host of problems related to diminished visual acuity and diminished quality of vision, including, without limitation, halos, blurry vision, glare, ghosting, starbursts, double vision, light sensitivity, contrast sensitivity, loss of depth perception, difficulty driving, especially at night, headaches, dry eyes and foreign body sensation.

Mr. Smith is represented by the Law Office of Todd J. Krouner in Chappaqua, New York.  Mr. Krouner represents victims of LASIK surgery throughout the United States.

A copy of the complaint is available here. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800.

Consumer Digest Quotes Krouner on LASIK Hazards

In the October 2015 issue of Consumer Digest, Todd J. Krouner is cited extensively in an editor’s note warning about complications of LASIK surgery.  In addition to criticizing the FDA for abandoning its oversight responsibilities, Consumer Digest echoes Krouner’s warning to consumers to: (1) avoid high volume LASIK facilities; (2) get an opinion from an ophthalmologist who does not perform LASIK surgery; (3) seek LASIK surgeons who have extra fellowship training in cornea; and (4) avoid bargain LASIK facilities that offer surgery for less than $1,000.

In the accompanying article, Krouner is critical of the FDA and LASIK surgeons who he contends underreport post-LASIK ectasia, the most devastating, vision threatening complication of LASIK.

“Almost Everyone” Is Not A Candidate For LASIK Surgery

In the “Health” column of the March 17, 2015 Journal News, the newspaper provided a half-page infomercial for a Rockland county LASIK surgeon who is promoting himself, and the supposed safety of this elective, cosmetic vision-altering procedure.

First, the article offers no news.  Second, the article properly should be marked “advertisement.”  Third, if the Journal News wishes to serve its readers, the reporter should warn of the hazards of LASIK surgery, even if the surgeon does not.

Morris Waxler worked for the FDA in the 1990’s.  He has called for a moratorium on LASIK surgery.  He says, “If I knew then what I know now, I never would have approved the lasers used for LASIK surgery.”  LASIK surgery involves cutting a corneal flap.  That severs corneal nerves.  50% of LASIK patients will suffer from dry eye.  The cutting of the flap will likely diminish night vision, in good cases. Consumer Reports states that nearly two-thirds of LASIK patients said they “were disappointed to find that they still had to wear glasses or contacts at least occasionally.”

Contrary to the “news” story, it is false to state that “Almost everyone is a candidate.”  Persons with pre-existing corneal disease, such as keratoconus, are not good candidates.  Persons with pre-existing dry eyes are not good candidates.  Persons with thin corneas are not good candidates. Persons who care about their quality of vision, and not just their visual acuity, are not good candidates.  Persons who think that they will not need reading glasses after LASIK are not good candidates.  The list is limited only by space.

Finally, if you are thinking about LASIK surgery, do not ask a LASIK surgeon who is in the business of selling LASIK; do not ask a lawyer like me, who has seen everything that can go wrong in LASIK go wrong.  Ask an ophthalmologist, such as a glaucoma specialist, who does NOT perform LASIK surgery, what he or she thinks of the procedure.  I doubt that the answer will be nearly as fluffy as was suggested in the Journal News infomercial.

One Doctor’s Excellent LASIK Results Tell Us Little About Patient Safety and Satisfaction For The Masses

A recent study from the Cleveland Clinic reports that the overwhelming majority of physicians who had LASIK surgery were satisfied.  The study notes that nearly 1 million patients have LASIK, or some similar form of corneal surgery (i.e., PRK), each year, and that 95% are satisfied.  “Just” 2% of the physicians reported “severe problems.”  Click here to read the study.

One obvious problem with the Cleveland Clinic study is that it is limited to the singular success of one LASIK surgeon, Ronald R. Krueger, M.D.  I know Dr. Krueger.  He is an amazing surgeon of great skill, education and integrity.  But it is dangerous to extrapolate his distinctive success to the nearly 1 million patients per year who do not have the privilege to consult Dr. Krueger as their LASIK surgeon.

What is the true success rate for the general population of LASIK patients?  Who knows.  Six years ago, in 2008, when I addressed the FDA, it promised a study on LASIK safety.  Six years later, we are still waiting.

It is hard to reconcile slanted industry reports of 80% patient satisfaction with a 2013 Consumer Reports study that found that “nearly two-thirds said they were disappointed to find that they still had to wear glasses or contacts at least occasionally.”  Click here to read the Consumer Report article.  It is also hard to reconcile the supposed 95% patient satisfaction rate with the image of the entire FDA LASIK Advisory Panel wearing glasses. (If only I knew how to take a selfie when I addressed that panel six years ago.)

If you still want LASIK, go to Dr. Krueger at the Cleveland Clinic.  If you cannot, ask to see your surgeon’s patient satisfaction reports (and I do not mean Yelp reviews).

LASIK Verdict Hall of Fame

On Monday, November 24, 2014, the New York Law Journal, in conjunction with Verdict Search.com, named Todd J. Krouner in its “Verdict and Settlements Hall of Fame: Medical Malpractice.”

The Hall of Fame verdict was $5.8 million in a LASIK malpractice case, in which the surgeon was negligent in screening the patient for eye surgery.  As a result, the patient developed post-LASIK ectasia, which is a vision threatening disease that impacts quality of vision, resulting in symptoms such as double vision, glare and halos.  The New York jury awarded, and the appellate court recently affirmed, $3.1 million just for the patient’s pain and suffering.  That pain and suffering award is the highest of its kind for an eye injury.

Together with Mr. Krouner’s previous $7.25 million verdict in Schiffer v. Speaker, Mr. Krouner has the two largest verdicts involving LAISK surgery negligence.

LASIK MALPRACTICE RE-TRIAL ORDERED AGAINST FRANK R. OWCZAREK, M.D.

PRESS RELEASE – FOR IMMEDIATE RELEASE

Thomas Baird v. Frank R. Owczarek, M.D. and Eye Care of Delaware, LLC In the Superior Court of the State of Delaware, Case No. N11C-09-241 RRC

On May 28, 2014, the Delaware Supreme Court reversed a jury verdict in favor of Frank R. Owczarek, M.D., Eye Care of Delaware, LLC, and Cataract and Laser Center, LLC (the “Defendants”) and ordered a new trial. Plaintiff Thomas Baird had sued the Defendants for medical malpractice involving LASIK eye surgery. Following an eight-day jury trial in April 2013, the jury returned a verdict in favor of the Defendants. The Delaware Supreme Court reversed and ordered a new trial on two ground

First, it found that the trial court abused its discretion after it learned that a juror had conducted internet research during the trial, contrary to its explicit instruction not to do so, but then declined to conduct any investigation concerning the substance of the juror’s internet research.

Second, the Delaware Supreme Court ruled that the trial court abused its discretion when it admitted evidence of informed consent, over plaintiff’s objection, when plaintiff made no claim for breach of informed consent.  In a case of first impression in Delaware, the Delaware Supreme Court held that: “Evidence of informed consent in a medical malpractice action could confuse the jury by creating the impression that consent to the surgery was consent to the injury.” The Delaware Supreme Court cited the appellate courts of six other states that have ruled similarly.

A copy of the Delaware Supreme Court’s decision is available here.

The parties’ briefs and oral argument before the Delaware Supreme Court are available here.

Plaintiff was represented by Todd J. Krouner, of The Law Office of Todd J. Krouner, and Bruce Hudson, of Hudson & Castle Law, LLC.  Defendants were represented by Joshua H. Meyeroff and Gregory McKee, of Wharton Levin Ehrmantraut & Klein.  For further information, please contact Mr. Krouner at 914-238-5800, or Mr. Hudson at 302-428-8800.

Record LASIK Verdict of $3.1 Million For Pain and Suffering Affirmed By Appellate Court

On September 4, 2014, a New York Appellate Court affirmed the substance of a $4.7 million judgment against a LASIK eye surgeon, and his New York City practice.

Following a nine-day trial in May 2009, a Manhattan jury awarded the patient $100,000 for past pain and suffering, a record $3,000,000 for future pain and suffering, $60,000 in past loss earnings and $740,000 for future loss of earnings.

On August 12, 2011, judgment was entered in the amount of $4,520,299.58.

On appeal, the LASIK surgeon challenged the statute of limitations and damage awards, among other things.  The statute of limitations in New York for medical malpractice is 2.5years, and is extended for continuous treatment.  At issue was a 30-month delay between the initial LASIK surgery in 2004 and the patient’s return in 2007 for blurry vision.  Showing “great deference” to the jury’s determination that the treatment was continuous, the appellate court upheld that portion of the jury’s verdict.

As a result of the eye doctor’s medical malpractice, the patient developed post-LASIK ectasia, which is a vision threatening disease of the cornea. Post-LASIK ectasia is a time bomb that frequently carries a long fuse of many years before it detonates.  Consequently, the appellate court’s statute of limitations decision is very important for LASIK victims in New York who may not have an injury until years after their eye surgery.

The patient complained about problems with the quality of his vision, including double vision, starbursts and halos.  He had chronic dry eyes.  He struggled at work, and could tolerate his rigid gas permeable contact lenses for only six hours a day.  Even through his driver’s license was unrestricted, the appellate court observed, “Even surveillance tape shown at trial by defendant establishes that plaintiff must depend on his wife and father for rides to work and other places.”

The $3,000,000 damage award for pain and suffering in an eye injury case is the largest reported appellate decision.

Plaintiff was represented by Todd J. Krouner of the Law Offices of Todd J. Krouner, in Chappaqua, New York.  Following Mr. Krouner’s $7.25 million verdict in Schiffer v. Speaker, he has the two largest verdicts for LASIK malpractice.

News Links

FDA Is Taking A Second Look At LASIK After 10 Years of Complaints:
http://video.ap.org/v/Legacy.aspx?partner=en-ap&g=ea31a1c3-47f6-4f79-b7b5-88b60b7d2b61&t=s60&p=enapus_enapus&&f=CAMOD

WebMD: Experts Advise NEW WARNING For LASIK:
http://www.webmd.com/eye-health/news/20080425/experts-advise-new-warnings-for-LASIK?src=RSS_PUBLIC

Alternatives To PERMANENT LASIK Surgery That You May Want To Consider:
http://www.cnn.com/2008/HEALTH/04/30/LASIK.alternatives.ap/index.html

Dallas, TX News:  LASIK Is Causing Suicides & Permanent Dry Eye Far Worse Than Contact Lenses:
http://www.dallasnews.com/sharedcontent/dws/fea/lifetravel/stories/DN-nh_LASIK_0520liv.ART.State.Edition1.464cd52.html

The Public Has The Right To Know The Truth About LASIK:
http://capecod.injuryboard.com/medical-malpractice/LASIK-and-the-Patients-Right-to-Know-.aspx?googleid=237642

FDA PANEL Is Asked:  “Is The 95% Success Rate Misrepresented?”
http://recent-business-news.com/data/articles_b17/idb2008.04.26.07.16.42.html

FOX NEWS: LASIK Now Under FED Scrutiny:
http://www.foxnews.com/video2/video08.html?videoId=6bdf68be-7048-4a62-8170-1e497251815c&sMPlaylistID=

NEW YORK TIMES: More Bad News For LASIK Doctors:
http://thelede.blogs.nytimes.com/2008/04/25/more-bad-news-for-the-LASIK-business/?hp

GOOGLE NEWS: FDA Takes Closer Look At BAD LASIK Results:
http://ap.google.com/article/ALeqM5hm4_Y2gN7uuJFU9yGiiiwV0BWDagD90936V83

CNN MONEY: LASIK is NOT Safe:
http://money.cnn.com/news/newsfeeds/articles/apwire/a0bb852cc268d5042e965b7a05771ee4.htm

FORBES: The FDA Examines “Quality of Life” of LASIK Patients:
http://www.forbes.com/forbeslife/health/feeds/hscout/2008/04/25/hscout614914.html

CNN WARNS: FDA Takes Closer Look At Patients Complaints:
http://edition.cnn.com/2008/HEALTH/04/24/LASIK.surgery.ap/index.html

WASHINGTON POST: LASIK Patients Describe Complications At FDA Hearing:
http://www.washingtonpost.com/wp-dyn/content/article/2008/04/25/AR2008042502061.html?hpid=topnews

MSNBC WARNS: FDA Examines Blurred Related Vision Problems:
http://www.msnbc.msn.com/id/24277759/

CBS WARNS: The FDA Wants To Take Another Look At The SAFETY of LASIK Surgery:
http://cbs3.com/health/LASIK.eye.surgery.2.707855.html

http://www.cbc.ca/consumer/story/2008/04/24/LASIK-panel.html

NEW YORK TIMES: Economy Slows And So Does LASIK Eye Surgery:
http://www.nytimes.com/2008/04/23/business/23LASIK-web.html?hp

ABC NEWS:  Lisa Stark Reports on the BLURRY OUTLOOK OF LASIK SURGERY:
http://abcnews.go.com/Health/BeautySecrets/Story?id=4665779&page=1

YAHOO BUSINESS: DANGERS OF LASIK EYE SURGERY:
http://biz.yahoo.com/ap/080423/LASIK_problems_fda.html?.v=1

New York Times Reporter, Abby Ellin Warns:  “TROUBLING EFFECTS OF LASIK SURGERY…”
http://www.projo.com/health/content/lb_LASIK_surgery_nyt_04-13-08_QM9BURH_v15.e092da.html

REUTERS Warns Public About LASIK Quality Being Investigated:
http://www.reuters.com/article/healthNews/idUSN1761471320080317?feedType=RSS&feedName=healthNews 

MSNBC Warns Public About LASIK Quality Being Investigated:
http://www.msnbc.msn.com/id/23689210/ 

YAHOO Warns Public About LASIK Quality Being Investigated:
http://news.yahoo.com/s/nm/20080317/hl_nm/dc_LASIK_fda_dc_1 

New York Times Warns Public About Post LASIK Quality of Vision Problems:
http://www.nytimes.com/2008/03/13/fashion/13SKIN.html?_r=1&pagewanted=1&ei=5070&en=01ec95cbca07e3e8&ex=1206158400&emc=eta1&oref=slogin 

Chicago Tribune Warns Public That LASIK Failure Rate CAN Be High:
http://www.chicagotribune.com/news/chi-LASIK_25feb25,0,7016699.story 

The North Carolina Observer Warns Public That LASIK Could Lead To Suicide:
http://www.newsobserver.com/150/story/920341.html 

“The Grey Sheet” Warns Public About LASIK Quality Being Investigated:
http://www.thegraysheet.com/fdcreports/story/search/submitSearch.do?doClear=true&subsNum=&publications=all&query=LASIK+&find_button.x=20&find_button.y=1

Did Army Surgeon, Scott Barnes, give a misleading testimony at the Emergency FDA LASIK hearing?
http://www.lasikcomplications.com/lasik-prk-refractive-surgery-in-the-military.html

 

Hurt from LASIK surgery?  Register for free to LASIKSugeryWatch.

It is vital that patients who have had poor outcomes
from refractive surgery be represented as a group with a voice by a patient advocacy organization such as LSW.
This has never been done before and the time is right to do it now.
http://www.lasiksurgerywatch.org

LASIK In The News   

More LASIK & FDA Related News/Videos

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LASIK Complications
Are Not Being
Reported To The FDA

What is LASIK?
Some Doctors Have
Stopped Doing
LASIK.

LASIK-risks lots of risks.....................................
LASIK Risks!

video
LASIK – Safe?
Effective? Risky?
Deceptive?

Reality LASIK with reality LASIK problems
True LASIK. True
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LASIK problems often have no plan B fix
No Plan B When
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The Dangers of LASIK - Diane Sawyer ABC
Diane Sawyer, ABC
News: The Dangers of
LASIK.

Per research, LASIK does more damage than people know
Per Research,
LASIK Does More
Damage Than
People Realize.

video
Is LASIK A “Terrible
Idea”?

video
NBC Nightly News:
Health Alert on
LASIK – Part 1

video
NBC Nightly News:
Health Alert on
LASIK – Part 2

 

 

CBS News: The Dark Side Of Eye Surgery – The potential risks and benefits of Lasik eye surgery is under review by the FDA. Dr. Jon LaPook reports on what happens when the popular procedure yields unexpected results.

MSNBC Video of The Today Show Special: Is Lasik Eye Surgery Really Safe?

MSNBC Video of NBC Nightly News Special: FDA Takes Closer Look at Lasik Surgery

Associated Press Article – April 28, 2008 – Analysts say Advanced Medical Optics unhurt by Lasik inquiry.

Wall Street Journal Article – April 26, 2008 – While past studies generally have found that 95% of Lasik patients are satisfied with their surgery, some patients have complained the surgery left them with damaged eyes and psychological problems.

New York Times – Associated Press Article – April 26, 2008 – In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son’s suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

Morning Star – Dow Jones Wire Article – April 25, 2008 – An FDA panel said Friday that the agency should improve its guidance on laser vision eye surgery to better inform patients of the surgery’s risks.

WebMD Article – April 25, 2008 – Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery.

New York Times – Associated Press Article – April 24, 2008 – Lost in the hoopla of ads promising that laser vision surgery lets you toss your glasses is a stark reality: Not everyone’s a good candidate and an unlucky few do suffer life-changing side effects — lost vision, dry eye, night-vision problems.

Wall Street Journal Article – April 24, 2008 – Laser vision surgery has helped millions of people see better without corrective lenses. But a small number of patients have experienced troubling aftereffects from the procedure, and the Food and Drug Administration has begun taking a closer look at their complaints.

  • NBC “Today Show” Coverage:
  • April 24: A decade after Lasik surgery first became available, unhappy patients like Matt Kosovolos are eager for the Food and Drug Administration to hear their grievances. NBC’s Chief Science Correspondent Robert Bazell reports.
  • April 25: Millions of Americans have undergone Lasik eye surgery safely, but some suffer side effects, prompting government hearings on the procedure. TODAY’s Dr. Nancy Snyderman comments.Disclaimer: The videos on this page are embedded directly from YouTube. If YouTube finds that these videos are copyright violation, they will be removed from this web page immediately.

FDA/CDRH confirms that only (3) LASIK centers have been investigated since the year 2000

In response to Dr. Michael Patterson, the FDA responds that ONLY 3 laser facilities were inspected from 2000 to 2008.
READ THE LETTER

Injury Board: Announces That The FDA Will Add 4 Items To Give More Informed Consent With LASIK:

SOURCE May 13, 2008

Patients harmed by Lasik eye surgery met with federal health advisers to complain of severe eye pain, blurred vision and even a son’s suicide. Advisers have asked the Food and Drug Administration (FDA) to warn the American public more clearly about the dangers that can arise from the popular surgery in which doctors cut a flap in the cornea, aim a laser under it and zap to reshape the cornea for sharper sight.  More than 700,000 people undergo Lasik eye surgery annually. While most benefit by gaining 20-20 vision or better, about one percent or less suffer serious, life-changing side effects: severe dry eye, glare, the inability to drive at night, and worse vision. In one case, the results of a botched Lasik eye surgery, which should never have happened because the patient did not qualify for the surgery, led the patient to commit suicide.

 

The FDA advisers have asked the agency to make the warnings about Lasik clearer by adding four items. First, they want the agency to add photographs depicting what people suffering from certain side effects might see, such as the glare that makes headlights look like bursts of light. Second, they want the warning to clarify how often patients suffer side effects, like dry eye, since some surgeons say there is a 48 percent chance of it happening, while others say there is a 31 percent chance. Third, the advisers want it to be made clearer the conditions that disqualify people from getting Lasik. Fourth, and finally, they would like it to be known that if nearsightedness is fixed by the surgery, it is proven that the patient will need to wear reading glasses in middle age, something that could be possibly avoided by not participating in the surgery. While no one is considering restrictions on Lasik, the FDA is joining major surgeons for a major study next year to better understand which patients have bad outcomes from the surgery.

Some patients pay dearly in bid for better eyesight: FDA panel urges clearer warnings about Lasik surgery

SOURCE April 26, 2008

WASHINGTON — In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son’s suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they’re hoping to throw away their glasses, just as the ads say.

Lasik surgery patient David Shell covers his face after speaking at a Food and Drug Administration hearing in Gaithersburg, Md., Friday, on Lasik surgery.
And while the vast majority benefit — most see 20-20 or even better — about one in four people who seeks Lasik is not a good candidate. A small fraction, perhaps 1 percent or less, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night.

“Too many Americans have been harmed by this procedure, and it’s about time this message was heard,” David Shell of Washington, D.C., told the Food and Drug Administration’s scientific advisers before their recommendation that the FDA provide clearer warnings. Shell held up large photographs that he said depict his blurred world, showing halos around objects and double vision, since his 1998 Lasik.

“I see multiple moons,” he said angrily. “Anybody want to have Lasik now?”

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway — and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

“As soon as my eyes went bad, I fell into a deeper depression than I’d ever experienced, and I couldn’t get out,” Gerard Dorrian read from his son’s suicide note.

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, “For the last two years I have suffered debilitating and unremitting eye pain.”

The testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.

But one thing is clear, said Dr. Jayne Weiss of Detroit’s Kresge Eye Institute, who chairs the FDA advisory panel: “This is a referendum on the performance of Lasik by some surgeons who should be doing a better job.”

The FDA advisers — a group of mostly glasses-wearing eye doctors — recommended that the agency make more clear the warnings it already provides for would-be Lasik patients:

– Add photographs that illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a huge “starburst” of light.

– Clarify how often patients suffer different side effects, such as dry eye. Some eye surgeons say 31 percent of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5 percent afterward. Other studies say 48 percent of Lasik recipients suffer some degree of dry eye months later.

– Make more understandable the conditions that should disqualify someone from Lasik, such as large pupils.

– And spell out that anyone whose nearsightedness is fixed by Lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip Lasik.

That’s a big reason why Weiss, the glasses-wearing ophthalmologist, won’t get Lasik even though she offers it to her patients.

“I can read without my glasses and … operate without my glasses, and I love that,” she said. “The second aspect is I would not tolerate any risk for myself. … Does that mean Lasik is good or not good? It means Lasik is good but not for everyone.”

Lasik is marketed as quick and painless: Doctors cut a flap in the cornea — the eye’s clear covering — aim a laser underneath it and zap to reshape the cornea for sharper sight.

The FDA agrees with eye surgeons’ studies that only about 5 percent of patients are dissatisfied with Lasik. What’s not clear is exactly how many of those suffer lasting severe problems and how many just didn’t get quite as clear vision as they had expected.

The most meticulous studies come from the military, where far less than 1 percent of Lasik recipients suffer serious side effects, said Dr. David Tanzer, the Navy’s Medical Corps commander. That research prompted Lasik to be cleared last year both for Navy aviators and NASA astronauts.

No one’s considering restrictions on Lasik — but the FDA joins eye surgeons for a major study next year to better understand who has bad outcomes.

News Stories Related to April 2008 FDA Ophthalmic Panel Meeting

YouTube Presentations of Hurt LASIK Patients
http://www.youtube.com/profile_videos?user=FDALASIKHearingVideo&p=v

CRS Today: Summary of Hurt LASIK Patients
http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.php

Slides of Damaged Patients/Presentations
http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353s1-00-index.html

Shows the FDA’s text version “Summary Minutes” of speakers
http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4353m1.htm

Patient Advocate, Dean Andrew Kantis, Challenges The FDA To Turn In ALL LASIK Patient Complaints:
http://www.youtube.com/watch?v=pTAHDLAwKkw&feature=related

April 25th, 2008:  FDA Emergency LASIK Panel Discussion Reports of Dissatisfied LASIK Patients:
http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.pdf

What is LASIK & Why Did The FDA Call For An Emergency FDA Panel On April 25th, 2008:
http://www.LASIKNewsWire.com

CBS NEWS: Katie Couric Talks About The Problems With LASIK Elective Eye Surgery:
http://www.cbsnews.com/sections/i_video/main500251.shtml?id=4047764n

CBS Interviews Hurt Patients Describing LASIK Results:
http://www.cbsnews.com/stories/2008/04/23/health/main4038420.shtml?source=related_story

 

Stem Cell Cornea Fix: Better Vision May Be In Your Own Eyes


Researchers Use Stem Cells From Patients’ Own Eyes to Restore Sight

ABC NEWS report June 23, 2010

More than 1.2 million Americans suffer cornea damage from injuries and more than 40,000 people a year undergo cornea transplants to repair otherwise irreversible eyesight damage, according to the American Academy of Ophthalmology.

But now, a new study suggests that many who suffer corneal damage by chemical burn may successfully restore their sight with transplants from their own eye stem cells.

Researchers in Italy studied a technique to repair damaged corneas by using patients’ own unscathed limbal stem cells — found at the edge of the cornea — to grow new tissue that was then grafted into the patient’s own eyes. The experiment was tried on 112 patients with corneas damaged by chemical burns. It was successful in 78 percent of patients, according to researchers, who followed the patients for 10 years after the procedure.

READ THE FULL STORY

Side effects continue to plague LASIK patients

Now, as the FDA investigates, one expert admits, “We screwed up”
SOURCE

By Abby Ellin

iStockphoto/Salon

The other day I got a prescription for eyeglasses. This is not newsworthy in itself except for one thing: More than two and a half years ago I had Lasik (laser-assisted in situ keratomileusis), specifically so I could toss away the spectacles I wore for near-sightedness. I knew that eventually I would need reading glasses, but I would, I was assured, be able to see long-distance for a long time.

Problem is, I can’t.

Not only is my vision blurred, but as I wrote in a 2008 article for the New York Times, I still see halos, and not the kinds with angels attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms. My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I signed an “informed consent” saying I understood all the possible side effects, but I certainly never knew that they might last indefinitely, and that they would be more than “annoying,” as my doctor promised. But nearly three years later, they are still here. And while I could get an “enhancement” — that’s industry parlance for another surgery to correct errors — frankly, the only thing I want near my eyes is mascara.

According to the American Society of Cataract and Refractive Surgery, most of the 13.6 million people in the United States who have had Lasik surgery since the first lasers were approved by the FDA in 1998 are pleased with the results. But others have experienced similar, if not worse, problems than I have.

Indeed, the estimated $2.5 billion industry has recently come under fire for its failure to acknowledge potential risks. Last spring, the FDA inspected about 50 Lasik facilities and found that many had no system in place for collecting and transmitting data to the FDA on patients’ reports of post-surgical “adverse events.”

And in August, Consumer Reports Health released the results of a survey, which found that 55 percent of Americans who’ve had laser vision correction surgeries are still wearing glasses or contacts some of the time. Fifty-three percent experienced at least one side effect within the first four weeks of the surgery; 22 percent of patients experienced them six months after surgery, especially dry eyes, halos, glare and starbursts around lights.

Still, the American Society of Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the organization. The researchers evaluated 19 studies involving 2,022 patients that specifically addressed patient satisfaction.

“Based on everything we know from the literature, and everything I know from any other elective procedure, Lasik eye surgery is the most successful elective procedure performed,” said Dr. Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a co-researcher on the study.

The experience of patients like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about four years ago, seem to support this assessment. Getting the procedure, he said, was one of the best decisions he has ever made. While he does experience some starbursts, he said “it’s not bothersome at all.”

But the FDA and others are taking note of what they call “quality of life” issues. In October, the FDA, the Defense Department and the National Eye Institute announced in October a three-year effort to assess adverse effects of Lasik. The effort will involve gauging how many active-duty military patients at the Navy Refractive Surgery Center in San Diego suffered post-surgical eye problems, and a series of national, multi-center clinical trials that will study the impact on quality of life following Lasik surgery in the general population. In addition, the FDA has reopened a public docket to receive comments through Nov. 15.

“We noted that there was little consistent evaluation of the issues,” said Mary Long, an FDA spokeswoman, about the reasons for why the study was initiated.

Erik J. Rupard, a doctor and clinical researcher with the U.S. Army, is among those who think such scrutiny is necessary. “Lasik is the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that those few of us who speak ill of it are dismissed as cranks and/or loonies,” he wrote in an e-mail message. “I saw lots of dry-eye complications in soldiers in Iraq who had undergone the procedure ostensibly because contacts are too unsafe in that dusty environment, and yet the Department of Defense has done no controlled studies to look at the cost — human and otherwise — of these post-refractive issues. I am a clinical researcher, and I know that Lasik, a cosmetic procedure, has never been subjected to the pre- or post-marketing scrutiny that we put even lifesaving drugs through.”

Surf the Web and you can find dozens of stories from people who have had post-Lasik difficulties: dry-eye, halos, glare. Some complications have resulted in corneal transplants. Over the last few years patient activists have bombarded the FDA with anti-Lasik e-mails, complaints and petitions.

Among them is John Hoge, 39, a businessman in Port Jefferson, N.Y., who suffered from night glare and halos and regrets not choosing the “zero risk option” of corrective lenses. A few years ago he got some experimental contact lenses that have largely taken care of the glare issue. They are expensive, he added, and are not covered by insurance.

While the FDA’s recent efforts have given some patient activists a modicum of peace, many do not feel it is enough. “By not inspecting every Lasik facility in this nation, how is the FDA to know if Lasik doctors are compliant?” said Dean Andrew Kantis, 40, a jet salesman in Fort Lauderdale, Fla., who has experienced double vision, starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web site LifeafterLasik.com.

Some experts believe the FDA should have taken more care when the first lasers were approved in 1998. “We screwed up,” said Morris Waxler, a former branch chief of the FDA’s Center for Devices and Radiological Health Office of Science and Technology from 1995 to 1999. “You know how some drugs have a black box warning —  it’s dangerous because of this, this and this — we could have done something comparable to that. We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials.”

Larry Pilot, a former associate director for compliance in the FDA’s bureau of medical devices, and currently a lawyer practicing food and drug law in Arlington, Va., agreed. “It appears that information to provide adequate informed consent was not sufficient for all prospective patients about occasions where a bad outcome could result,” he said. “The present dissatisfaction rate of 5 percent is very high. Personally and professionally, I am very disappointed in the FDA.”

Spokeswoman Long refutes the notion that the FDA was errant. “The FDA has reviewed safety and effectiveness information included in the manufacturer’s applications for approval,” she wrote in an e-mail message. “We found them to be safe and effective when used as indicated and will continue to monitor their safety and effectiveness, in addition to taking necessary and appropriate steps to protect the public health.”

Timothy A. Ulatowski, director of the FDA’s Office of Compliance at the Center for Devices and Radiological Health, sent out letters to Lasik ambulatory facilities last May reminding them that all risks must be mentioned in every Lasik advertisement online, in print, radio or TV.

“As part of our ongoing review of Lasik and its impact on public health, we continue to look at various aspects of Lasik advertising and how we can better improve public health,” said Long.

Still, an informal online search showed dozens of doctors’ Web sites that do not mention risks or side effects.

As for the new study, Larry Pilot is not impressed. “The FDA is beginning to do what should have been done 10 years ago,” he said. “The bottom line here is that upwards of scores of thousands of human eyes have been irreversibly damaged unnecessarily.”

Dr. Solomon disagreed, maintaining that the FDA clinical trials on Lasik lasers were “rigorous” and “well-performed.” “I think the FDA did an outstanding job at evaluating the technology,” he said. “And the technology and procedure since approval have only gotten better.”

As for me, if I had to do it all over again I wouldn’t. But hindsight, alas, is 20-20.

Abby Ellin is the author of “ Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and How Parents Can (and Can’t) Help .”  She lives, works, and tries to see in New York City.

Former FDA Chief of Medical Devices, Morris Waxler, PHD, Warns Public About Dangers of LASIK – Aired February 25th, 2010 on Good Morning America

Updated February 25, 2010

Leave it to the FDA to deny that they ‘MESSED UP’. Mr. Waxler admitted 10 years after his retirement what most LASIK casualties have been trying to say since the late 1990s. The FDA continues to downplay the risks further allowing more people to get damaged from this procedure – when is enough enough? At least Mr. Waxler has taken his time to actually talk to damaged patients on a personal level (myself included), which is more than I can say for the FDA. I commend Mr. Waxler for his honesty.

Could LASIK Lead to ‘Permanent Vision Problems’?

FDA Must Stop ‘Epidemic of Permanent Vision Problems,’ Former Proponent Says
SOURCE

September 22, 2010

A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA.

Morris Waxler, who is now an independent regulatory consultant, filed a citizens petition today urging the agency to take steps to stop what he calls “the epidemic of permanent vision problems” caused by LASIK.

Waxler’s petition implores the FDA to take actions to crack down on the procedure, including issuing a public health advisory that warns the public about the dangers associated with LASIK and implementing stricter controls over LASIK device manufacturers and practitioners who perform the surgery.

In the petition, Waxler included data that he said were evidence that “LASIK causes persistent vision problems with an overall success rate of less than 50 percent; a failure rate of more than 50 percent.”

Waxler said his change of heart came about after he retired from the FDA in 2000. He started getting complaints from people who suffered serious side effects from the procedure, including seeing halos, impaired night vision and excessive glare.

He was surprised when he looked back at the data presented when LASIK was undergoing the approval process in the late 1990s.

“When I looked back at that data, there was a tremendous consistency that show these problems exist in about 18 percent of people who had LASIK, most of them after I left the FDA,” he said.

Some doctors, however, say while they agree with the estimate that thousands of people have had problems after having LASIK surgery, they stress that the vast majority of people are very happy after having the procedure done.

“Ninety-nine percent of people who have had LASIK have excellent results,” said Dr. Robert Cykiert, clinical associate professor of ophthalmology at NYU Langone Medical Center. “Millions of people have had the procedure done with a high success rate.”

Doctors, Patients Say LASIK Procedure Is Safe and Effective

One of those satisfied patients is Andy Ng of Long Island, N.Y.

Ng had LASIK in 2004. He decided to go through with the procedure because he got tired of spending hundreds of dollars on glasses that needed special lenses and would get banged up because of his participation in sports. He also found contact lenses cumbersome and time-consuming.

He said he already knew about the side effects before he went in for the surgery.

“I knew for a fact I was going to have halos at night,” Ng said. He added that aftewards, the halos didn’t make much of a difference for him.

“I have no other problems, such as floaters, dry eyes, etc.,” he said.

Doctors stress that LASIK is no different from any other medical or surgical procedure.

“We always would like to have any medical procedure or surgical procedure that works 100 percent of the time, but that doesn’t exist,” Cykiert said.

“Complications do happen, but it’s rare, and often, we’re not sure why,” said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai School of Medicine.

Doctors also say that even if a patient is an ideal candidate, the surgeon is very skilled and the equipment is top-of-the-line, problems can still occur, so it’s difficult to predict whether someone will suffer from LASIK-associated side effects.

Communication, Information Vital to Minimizing LASIK Risk

Not everyone is a candidate for LASIK, and doctors say it’s important for prospective patients to understand that. People with vision that continues to get worse, extremely poor vision, certain characteristics of the cornea and some diseases may not be suitable candidates for the procedure.

“Doctors need to take time with a patient and get all the information they need,” Asbell said. “Doctors also need to learn what the patient’s expectations are. If a person wants 20/15 vision, they may not be the best candidate.”

Experts also say there are still things about LASIK that they just don’t know.

“It’s very hard to quantify these side effects, such as determining how to measure how bad things like glare and halos are,” Asbell said. “It’s hard to pin down risk factors that differentiate the people who have problems from the ones that don’t so we can try to learn more.”

“There are many things we still don’t know about the cornea, such as physiology and variability in structure, so we don’t know why some patients bounce back and others don’t,” Cykiert said.

Cykiert also said that the thousands of people who have problems have a legitimate reason to complain to the FDA, and that information they provide can be helpful for everybody.

“That’s how we’re going to make the procedure safer and better,” he said.

And that’s also how there may eventually be more people like Andy Ng, who has no complaints about his LASIK experience.

“The procedure is one of the best things out there for the eyes,” he said.

ASCRS President Denies Accusations of Former FDA LASIK Chief

SOURCE

In a scathing three-page letter to R. Doyle Stulting, MD, PhD, president of the American Society of Cataract and Refractive Sugeons (ASCRS), Morris Waxler, PhD, the head of the Food and Drug Administration (FDA) branch responsible for reviewing data on LASIK between 1996 and 2000, accused the ophthalmic organization of blatantly ignoring several of the risks involved in PRK and LASIK procedures.

In the letter dated May 7, 2010, Dr. Waxler, who recently said the FDA’s approval of LASIK devices was a mistake, specifically criticizes a proposed ASCRS phase 2 keratectasia trial, claiming it is unethical and puts patients at risk of post-surgical corneal failure, induces corneal thinning and bulging, and increases the likelihood of other permanent LASIK complications.

“The ASCRS Phase II keratectasia trial proposes doctor-induced (iatrogenic) injury in vulnerable patients in order to study iatrogenic insult, instead of mitigating thinning and bulging of the cornea by not performing LASIK and by determining how to stabilize corneas already damaged by LASIK,” writes Dr. Waxler, who goes on to say he will do everything he can to block the approval of such a study.

In support of his claims, Dr. Waxler cites several clinical reports that, among other statistics, say 15% to 30% of LASIK patients suffer from eye pain, glare, halos, dry eyes, night vision and other problems, and 1% of LASIK patients have keratectasia.

Dr. Waxler also accuses the FDA of being “complicit with LASIK manufacturers, ASCRS, and others in minimizing multiple permanent vision complications.” He asked for Dr. Stulting’s cooperation in helping to eliminate unnecessary LASIK through more transparency about the short-term “wow” effects versus the reality of permanent eye injury.

In a response letter dated Sept. 20, 2010, Dr. Stulting broadly denies all of the claims and accusations made by Dr. Waxler, calling his view of LASIK “misinformed, unsupported by evidence, and lacking in balance and perspective.”

“LASIK was first approved by the FDA on your watch, following all the required FDA protocols and guidance documents created to measure safety and effectiveness.  In fact, laser vision correction is one of the most studied elective surgical procedures, with 7,830 patients representing 16,502 eyes in US FDA clinical trials from 1993 to 2005 – not to mention more recent submissions to the FDA and thousands of other patients reported in the published literature.  The FDA review process is more stringent than that of any other country in the world,” he stated.

Addressing Dr. Waxler’s accusation that the ASCRS Phase II keratectasia trial poses a danger to patients, Dr. Stulting called the assertion “plainly wrong,” saying Dr. Waxler does not have access to the protocol he references, making it impossible for him to make a responsible, meaningful comment. “Your negative and accusatory comments are inappropriate, misleading, and without foundation,” he said.

Dr. Stulting also said the statistics Dr. Waxler cited were inflated and inconsistent with existing data. For example, the report that Dr. Waxler’s used to claim that at least 1% of LASIK patients have keratectasia actually gave the rate of 0.66%, and even that is the highest estimate in the literature, Dr. Stulting said. Published estimates of its incidence actually range from 0.0004% to 0.66%, he said.

Dr. Stulting also accused Dr. Waxler of manipulating data by referencing the incidence of keratectasia outside of the United States, and on another occasion referencing the results of LASIK treatments with a laser designed more than 20 years ago that is not commonly used in the United States today.

“In summary, your letter is filled with false statements, incorrect citations of the published literature, references that do not fairly represent the existing literature, mischaracterization of a study protocol you have never seen, incorrect reference to outcomes of PRK as if they were for LASIK, citation of results for a laser designed two decades ago as if were representative of modern lasers, mischaracterization of results from older lasers as “better than most,” reference of a graph that does not exist in the reference you cite, and misrepresentations of the actual performance of modern excimer lasers for the correction of refractive errors,” Dr. Stulting said.

Given Dr. Waxler’s experience and Dr. Stulting’s influence with industry, I’d be more inclined to believe Dr. Waxler!

$5.6 million against Kevin Niksarli, M.D., for LASIK malpractice

SOURCE
Johnson Devadas and Saramma Devadas v. Kevin Niksarli, M.D., Manhattan LASIK Center, PLLC, and NewSight Laser Center, PLLC

New York County, Supreme Court of the State of New York Index # 107637/07

Manhattan, NY (PRWEB) June 14, 2009 — On Wednesday, June 10, 2009, a jury in New York City returned a verdict of nearly $5.6 million against Kevin Niksarli, M.D., for LASIK malpractice. The verdict consisted of an award of: $2,360,000 for the patient’s loss of income; $3,100,000 for the patient’s pain and suffering, including loss of life’s enjoyment; and $120,000 for the patient’s wife’s claim for loss of her husband’s services and consortium. This is the second largest verdict ever for LASIK malpractice.

The lawsuit, Devadas v. Niksarli, Index No. 107637/07 (Supreme Court New York County), was commenced on May 31, 2007. The trial began on May 20, 2009, and lasted 10 days. The jury of three men and three women deliberated for 2 and one-half days. The Honorable Doris Ling-Cohan presided over the trial.

The plaintiff, Johnson Devadas, is a pharmacist who lives and works in Queens, New York. On March 25, 2004, Dr. Niksarli concluded that Mr. Devadas was a suitable candidate for LASIK surgery. However, plaintiff’s medical expert testified that he was not. Paul Donzis, M.D., and ophthalmologist and cornea specialist from Los Angeles, California, testified that prior to the elective surgery, the plaintiff had a contraindication to LASIK surgery, forme fruste keratoconus. Dr. Donzis explained that forme fruste keratoconus was a stable or abortive form of keratoconus that would not likely progress without LASIK surgery. However, as a result of the LASIK surgery, it caused the cornea to develop post-LASIK ectasia, or a progressive thinning of the cornea. Ectasia causes problems with visual quality, including blurriness, halos, double vision, glare, contrast sensitivity, starbursts and a host of related phenomena involving the distortion of light as it passes through the diseased cornea.

In addition to Dr. Donzis, plaintiffs called Albert Lyter, Ph.D., from Raleigh, North Carolina. Dr. Lyter is a former federal agent trained in ink dating analysis. Dr. Lyter testified that Dr. Niksarli intentionally artificially aged a note in his chart concerning his purported conversation with the patient and his wife concerning the risks, benefits, and alternatives to LASIK surgery.

Anthony Gamboa, Ph.D., also testified as an expert in vocational economics concerning plaintiff’s loss of income. Dr. Gamboa is from Miami, Florida.

Dr. Niksarli called Wing Chu, M.D., from New York City, to discuss his so-called independent examination of the plaintiff. On cross-examination, Dr. Chu testified that his version of the Hippocratic Oath, in part, translates to first do no harm to any ophthalmologist.

Dr. Niksarli also called Peter Hersh, M.D., from Teaneck, New Jersey, as his cornea expert. On cross-examination, Dr. Hersh indicated that he only testified for defendants’ counsel, who had previously represented him in his own medical malpractice case.

The plaintiffs were represented by Todd J. Krouner, from Pleasantville, New York. In 2005, Mr. Krouner obtained the largest verdict for LASIK malpractice, in the amount of $7.25 million. See Schiffer v. Speaker, Index No. 101191/03 (Supreme Court New York County 2005).

The defendants were represented by Neil H. Ekblom, of Clausen Miller, in New York, NY. Prior to this verdict, Mr. Ekblom’s webpage boasted that he had obtained a string of 19 consecutive defense verdicts.

For further information, please contact Todd J. Krouner at (914) 769-8700.

Study: Glasses After Lasik

SOURCE

They had Lasik surgery but still need glasses. A new Consumer Reports Health survey finds that while 80 percent of people who’ve had Lasik or other laser vision-correction surgery are “completely” or “very satisfied,” 55 percent of those who had gone through the procedure said they still had to wear glasses or contact lenses at least occasionally.

Although many expected this would be the case, most (61 percent) said they were disappointed about that. The majority of respondents (56 percent) say they had the surgery-often pitched as an alternative to glasses-to correct nearsightedness.

The survey was of 793 adults who had laser vision correction surgery since 2001.

“The typical national price (per eye) for laser vision surgery is $1,657, yet the survey reveals wide variation in costs per eye.

Seven percent of consumers who reported their costs said they paid less than $499 per eye; 12 percent paid between $2,500 and $3,999 per eye; and 4 percent shelled out $4,000 or more per eye. Twenty-three percent of respondents were unsure of what they paid.

“The surgery is not without risk: 53 percent of those surveyed experienced at least one side effect within the first four weeks of the surgery and 22 percent of patients experiencing them six months after surgery, especially dry eyes and visual symptoms like halos, glare, and starbursts around lights.

“The majority (56 percent) of respondents had the surgery to correct nearsightedness, while others had it done for astigmatism (35 percent) and farsightedness (20 percent).

“Satisfaction with one’s surgeon is key-it strongly predicts overall satisfaction with laser eye surgery, even more so than where the procedure is performed. Thus, choosing a surgeon carefully is more important than choosing the pace of surgery.

Consumer Reports Health offers detailed tips for selecting the right surgeon.

Consumer Reports Health has noted in a previous report that some of the low prices advertised for vision surgery can be potentially misleading. Among other things, the price quoted may be for only one eye. And if a free consultation is offered, you have a right to just that.

The U.S. Food and Drug Administration has taken a hard look at Lasik eye surgery, spurred in part by a lack of reliable data about how often side effects occur. “Laser vision correction surgery is a largely unchecked industry and consumers need to know the right questions to ask to be sure they’re protected and that they’re getting good quality care for their money,” said John Santa, M.D., director of the Consumer Reports Health Ratings Center. “Vision correction surgery is increasingly popular but there is a concerning lack of unbiased, concrete evidence about its safety and efficacy.” It’s not easy to sort through the evidence surrounding vision-correction surgery, as much of the current available research comes from surgeons who do the procedure, and who may be more likely to publish positive results, said Santa. In addition, various surgeries and lasers offer advantages in specific circumstances, but Santa notes that the lack of well-designed comparisons makes it impossible at this time to identify one laser vision corrective surgery as better than another overall.

Since the vast majority of consumers pay most or all of the costs of the procedures out of pocket, the new Consumer Reports Health Patient Power Tool Kit, available to subscribers, will help consumers get high quality care at the right price. The tool kit will: “Help determine whether you’re likely to be satisfied based on your personal odds and expectations. “Provide detailed information from consumers who have undergone the surgery. “Give a safety assessment of laser vision-correction surgery, based on the latest evidence. “Guide you through the decision process, including key questions to ask your surgeon and red flags that should alert you about getting a second opinion. “Tell consumers what to expect before, during, and after the surgery. “Detail the costs of surgery, insurance coverage, and payment strategies. The tool kit is available to subscribers at www.ConsumerReportsHealth.org.

Synthetic Fibers to Reverse Blindness

SOURCE

Eric Bland, Discovery News – June 1, 200

Synthetic fibers can now be embedded with three, and possibly more, drugs or proteins. The new fibers could be woven into a variety of materials that have unique and novel properties — such as reversing blindness.

“The ultimate idea is to implant this material into the eye,” said Bin Dong, a scientist from Drexel University who, along with Gary Wnek and Meghan Smith of Case Western University, detailed their work in the journal Small.

“One protein will eat the scar tissue away, and the other will help induce the differentiation of retinal progenitor cells,” said Dong.

Previously scientists were only able to include one drug or protein inside an electrospun fiber because the two would often interact with each other in ways that would negate or modify their effects.

To get around this limitation, the Drexel and Case Western scientists put the drugs and proteins inside tiny capsules, which stop the molecules from interacting with each other until they break apart.

For their first tests, the scientists incorporated both bovine albumin serum (BAS) and epidermal growth factor (EGF) into the same electrospun fiber. Each molecule was also linked to a particular fluorescent dye that appears under special light. Red for BAS, green for EGF.

A fleece or nylon that glows different colors at different times is the beginning, though. Restoring vision to the blind could be the first use for these drug- and protein-containing fabrics.

Working with Michael Young, an ophthalmologist at the Schepens Eye Research Institute, the Drexel and Case Western University researchers are trying to create a biodegradable synthetic fabric that could return sight to blind people.

Surgically implanted onto the retina during a 45-minute operation, the protein-equipped fabric would do two things. First, proteins in the fabric would eat away at the scar tissue created by diseases like retinitis pigmentosa and macular degeneration.

Once that’s done, other capsules would break apart and release a growth factor that would encourage cultured retinal progenitor cells on top of the fabric to create new, light-detecting cells. The nanofiber material would then provide a place for these new cells attach to and grow on. Once the cells were established — between 24 and 48 hours — the material would naturally degrade.

“We’ve been able to show that in mice we can restore some kind of meaningful vision,” said Young. “Pigs have compatible cells, and the next step is to restore vision for them as well.”

If the animal trials go well, Young estimates that it will be a minimum of three years before any human trials of the material can be attempted.

“It sounds very exciting that they were able to incorporate multiple proteins,” said Paula Hammond of the Massachusetts Institute of Technology, who works with electrospun materials.

“This could be especially interesting for tissue regeneration and wound healing applications,” said Hammond.

Stem Cells to Make Lasik Obsolete

April 19, 2009 by SOURCE

The Mice with Stem Cell Eyes

Researchers at University of Pittsburgh School of Medicine have successful restored the vision of mice with corneal defects using stem cells treatments. The stem cells were injected directly into the cornea of the mice. Upon completion of the stem cell treatment the eyes of the mice are reported to look no different than the undamaged eyes of other mice.

Further the musculus subjects of this corneal stem cell experiment displayed no signs of immune system rejection, even when human stem cells were used during the test. This suggests that the immune system may not discriminate against stromal stem cells in the eye even when they are not harvested from the same species.

The main argument against stem cell research has historically been voiced by those who disagree with the destruction of human embryos for the sole purpose of stem cell harvesting. However, the research at University of Pittsburgh School of Medicine may have found a way to side step the issue. At least as far as our eyes are concerned. If mice, with one of the most robust immune systems in existence, do not reject human stem cells injected into their corneas, then it stands to reason that humans, who have a much less proactive immune system, would have no problem accepting injections of rodent stem cells.

While for many of us having rat-eyes might not be the most appealing thought, the benefits surely outweigh the gross factor. Unlike dangerous corneal replacement surgery and Lasik (laser surgery), both of which are temporary solutions which eventually degrade, corneal stem cell therapy appears to be a permanent solution. Add the reduced risk of immune system rejection, and a near endless supply of non-morally ambiguous stem cells and we may be witnessing the end of Lasik.

K-State professor awarded $1.48 million to study LASIK complications

SOURCE

Contact: Gary Conrad
gwconrad@k-state.edu
785-532-6662
Kansas State University

Gary Conrad, a university distinguished professor at Kansas State University’s Division of Biology, has received a four-year grant renewal of $1.48 million from The National Eye Institute of the National Institutes of Health to study the cornea.

“The NIH renewal will make Conrad’s grant the longest continuously funded R01 grant in the state of Kansas at 41 years,” said Jim Guikema, K-State associate vice president for research.

From the beginning, Conrad has been fascinated by the unique structure of the cornea.

“Among all body tissues, the cornea is unique in being transparent, very highly innervated, free of blood vessels and yet composed of three layers of living cells,” he said.

Conrad’s research on embryonic development of the eye has led to knowledge that could possibly improve LASIK surgery. He and his research associates have identified a difference in the connective tissue of normal corneas compared to those that have been cut during LASIK.

LASIK, which stands for laser-assisted in situ keratomileusis, is a surgery using a laser to reshape the cornea as an alternative to wearing glasses or contact lens. During the procedure a thin-hinged flap is cut in the front of the cornea and peeled back out of the way to allow the laser to reshape the corneal connective tissue underneath the flap. When the laser is finished the flap is pulled back to its original position.

It was once believed that the flap would re-adhere permanently. However, the unique connective tissue of the cornea and a lack of blood vessels limit its ability to fully heal even years after the procedure,” Conrad said. “A trauma to the face, such as impact from an automobile air bag provides enough force to dislodge the flap, reopening the cornea, infecting it with dirt and debris, and causing instant loss of visual acuity.

After LASIK, differences in the structure of sugar molecules made the cornea prevent cut nerve ends from regenerating, as well as preventing the flap from re-adhering. However, the National Institutes of Health grant renewal will enable the lab group to test a possible solution that would strengthen the stromal flap and allow it to permanently bind back to the cornea after LASIK, Conrad said. It uses a combination of riboflavin and UVA light to permanently cross-link the connective tissue of the flap to the underlying corneal connective tissue. The treatment is currently in clinical trials in the U.S. for another eye dysfunction known as keratoconus.

The density of sensory nerve fibers that normally develop in our cornea is higher than anywhere else on the surface of our entire body,” Conrad said. “However, they regenerate extremely slowly if they are cut, so if we could get those nerves to regenerate, it would be a major medical advance.”

Since the grant began in 1971, Conrad’s lab group has discovered many properties of embryonic and adult corneas. He credits these accomplishments to the research professors, postdoctoral research associates, graduate students, research assistants and undergraduates in his lab who co-author many research publications that have made continuing grant funding possible.

His closest colleagues include his wife, Abigail Conrad, a K-State molecular, cellular, and developmental biologist; Yuntao Zhang, a K-State structural carbohydrate chemist; Peter Lwigale, a 2001 K-State doctoral graduate in biology and now an assistant professor at Rice University; Scott McCall, a K-State senior in biology and biochemistry and a 2008 Goldwater Scholar from Parker, Colo.; and Conrad’s first doctoral student Gerald Hart, director of the department of biological chemistry at the Johns Hopkins University School of Medicine, Baltimore, Md.

Conrad is known for mentoring and encouraging undergraduates in his lab. As a result, Conrad has recommended McCall for a summer position in Hart’s lab, researching structural chemistry.

“Our molecular biology research is only as good as our K-State freshmen dishwashers and autoclavers, so we try to train them carefully, listen to their questions, and counsel them as our closest research colleagues,” Conrad said. “They teach us many things.”

UK reporter seeks comments on LASIK

SOURCE

Why did my fabulous laser eyes go lazy again?
By Victoria Lambert
07th March 2009

Quote:
By the next morning I had full and fantastic vision. No hitches, no pain and I honestly thought I would never look back. On a good day, I could see for miles.

Fast-forward to 2009, and here I am wearing specs again. I can’t even drive without them.

Am I a scientific freak? Or will this reversal eventually happen to all the estimated 70,000 Britons who undertake laser eye surgery annually?

Quote:
Have you had a similar experience to Victoria? If so, email health@mailonsunday.co.uk

Laser eye surgery – you could be risking blindness

SOURCE

Monday, February 16, 2009, 09:16

Safety lawyers are warning Somerset residents that they could be gambling with their sight if they choose to undergo laser eye surgery.

The Association of Personal Injury Lawyers (APIL) has issued a warning stating that because the procedure is unregulated, patients could end up being treated by doctors without the right skills or experience.

APIL chief executive Denise Kitchener said: “It is imperative to ask the right questions before undergoing laser eye surgery.

“At the moment it is the patient’s responsibility to investigate the practitioner’s skills and training, and the only legal demand for doctors is that they are registered with the General Medical Council.

“The fact the industry is not regulated in any way is shocking, as someone who is inexperienced and has no specific training in this area can perform the surgery. This means there is a huge disparity in the quality of treatment available.”

The Government’s clinical watchdog, the National Institute for Clinical Excellence, says laser eye surgery should not be offered to patients routinely on the NHS, and that it is the NHS that often has to pick up the pieces when private surgery goes wrong.

“Many injuries are the result of patients not receiving appropriate counselling, or not being able to see a qualified ophthalmologist before and after the operation,” said Ms Kitchener.

“People may not realise the practice is unregulated – it is commonplace today to see it widely advertised, and the assumption would be that it is a safe procedure. While we’re sure there are many skilled practitioners, the danger comes from the ones who are not competent.”

For further information, visit the APIL website at www.apil.org .uk.

Lawmakers target inferior Lasik eye procedures

Feb. 21, 2009
Las Vegas Review-Journal

By ANNETTE WELLS

Quote:
AB196 adds to existing law regulating refractive eye surgery centers by requiring that ophthalmologists be licensed to perform the procedures through the Nevada State Health Division.

The bill also requires that facilities that offer refractive surgery ensure that a licensed ophthalmologist perform those procedures and that the ophthalmologist is available for preoperative and postoperative care.

The bill also authorizes the state’s health division to issue a cease and desist order if it learned a refractive surgery facility is operating without a license.

Link to full text of article

NEI lists LASIK as a cause of cataracts

SOURCE

Quote:

The DLS technique will now assist vision scientists in looking at long-term lens changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating glaucoma, and surgical removal of the vitreous gel within the eye, a procedure known to cause cataracts within six months to one year.

Full text of the press release:

For Immediate Release
Thursday, January 8, 2009

National Eye Institute
496-5248

Katherine K. Martin
NASA Glenn Research Center
216-433-2406

From Outer Space to the Eye Clinic: New Cataract Early Detection Technique

Patients and Astronauts Benefit from NEI-NASA Collaboration

A compact fiber-optic probe developed for the space program has now proven valuable for patients in the clinic as the first non-invasive early detection device for cataracts, the leading cause of vision loss worldwide.

Researchers from the National Eye Institute (NEI), part of the National Institutes of Health, and the National Aeronautics and Space Administration (NASA) collaborated to develop a simple, safe eye test for measuring a protein related to cataract formation. If subtle protein changes can be detected before a cataract develops, people may be able to reduce their cataract risk by making simple lifestyle changes, such as decreasing sun exposure, quitting smoking, stopping certain medications and controlling diabetes.

“By the time the eye’s lens appears cloudy from a cataract, it is too late to reverse or medically treat this process,” said Manuel B. Datiles III, M.D., NEI medical officer and lead author of the clinical study. “This technology can detect the earliest damage to lens proteins, triggering an early warning for cataract formation and blindness.”

The new device is based on a laser light technique called dynamic light scattering (DLS). It was initially developed to analyze the growth of protein crystals in a zero-gravity space environment. NASA’s Rafat R. Ansari, Ph.D., senior scientist at the John H. Glenn Research Center and co-author of the study, brought the technology’s possible clinical applications to the attention of NEI vision researchers when he learned that his father’s cataracts were caused by changes in lens proteins.

Several proteins are involved in cataract formation, but one known as alpha-crystallin serves as the eye’s own anti-cataract molecule. Alpha-crystallin binds to other proteins when they become damaged, thus preventing them from bunching together to form a cataract. However, humans are born with a fixed amount of alpha-crystallin, so if the supply becomes depleted due to radiation exposure, smoking, diabetes or other causes, a cataract can result.

“We have shown that this non-invasive technology that was developed for the space program can now be used to look at the early signs of protein damage due to oxidative stress, a key process involved in many medical conditions, including age-related cataract and diabetes, as well as neurodegenerative diseases such as Alzheimer’s and Parkinson’s,” said NASA’s Dr. Ansari. “By understanding the role of protein changes in cataract formation, we can use the lens not just to look at eye disease, but also as a window into the whole body.”

The recent NEI-NASA clinical trial, reported in the December 2008 Archives of Ophthalmology, looked at 380 eyes of people aged 7 to 86 who had lenses ranging from clear to severe cloudiness from cataract. Researchers used the DLS device to shine a low-power laser light through the lenses. They had previously determined alpha-crystallin’s light-scattering ability, which was then used to detect and measure the amount of alpha-crystallin in the lenses.

They found that as cloudiness increased, alpha-crystallin in the lenses decreased. Alpha-crystallin amounts also decreased as the participants’ ages increased, even when the lenses were still transparent. These age-related, pre-cataract changes would remain undetected by currently available imaging tools.

“This research is a prime example of two government agencies sharing scientific information for the benefit of the American people,” said NEI director Paul A. Sieving, M.D., Ph.D. “At an individual level, this device could be used to study the effectiveness of anti-cataract therapies or the tendency of certain medications to cause cataract formation.”

The DLS technique will now assist vision scientists in looking at long-term lens changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating glaucoma, and surgical removal of the vitreous gel within the eye, a procedure known to cause cataracts within six months to one year. It may also help in the early diagnosis of Alzheimer’s disease, in which an abnormal protein may be found in the lens. In addition, NASA researchers will continue to use the device to look at the impact of long-term space travel on the visual system.

“During a three year mission to Mars, astronauts will experience increased exposure to space radiation that can cause cataracts and other problems,” Dr. Ansari explained. “In the absence of proper countermeasures, this may pose a risk for NASA. This technology could help us understand the mechanism for cataract formation so we can work to develop effective countermeasures to mitigate the risk and prevent it in astronauts.”

The NASA John H. Glenn Research Center is one of NASA’s 10 field centers, empowered with the resources for developing cutting-edge technologies and advancing scientific research that addresses NASA’s mission to pioneer the future in space exploration, scientific discovery and aeronautics research. Working in partnership with government, industry and academia, the Center serves to maintain the U.S. economy’s global leadership while benefiting the lives of people around the world. For more information about NASA Glenn and its programs, visit www.grc.nasa.gov.

The National Eye Institute (NEI), a component of the National Institutes of Health, is the federal government’s lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Web site at www.nei.nih.gov.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Nevada Lasik Company Investigated by State

Updated: Oct 29, 2008 09:10 PM EDTThere is an update on an investigation of a local Lasik clinic. State authorities say they’re nearing the end of their review of the Valley Eye Center. Colleen McCarty (Las Vegas Now/Eyewitness News) first broke the story of alleged malpractice at the clinic.

The State Attorney General’s Office plans to complete its investigation of the Valley Eye Center within the next few weeks. Investigators have been exploring allegations that the administrator of the clinic practiced medicine without a license, a claim he adamantly denies.

Suit has been filed against the clinic alleging malpractice and to administrator Vikas Jain, fraudulent concealment. Jain, they claim, provided their pre and post operative care — procedures that, according to the lawsuits, only a licensed doctor may perform.

Jain lost his medical license in 2005 for harming more than 20 patients in the state of Ohio.

CLICK HERE for the full story

Lasik Surgery Results in Worse Vision and Never-Ending Pain

SOURCE

According to Dr. Kerry Soloman, who did a study of Lasik’s safety for the American Society of Cataract and Refractive Surgery, a full five percent have poor results. These can be worse vision — even blindness — constant eye pain, blurred vision, dry eyes, and a variety of other distressing visual aberrations. Interestingly, people who end up with corrected vision but permanent eye pain are considered successes by the surgeons who do the procedure.

About 48% — nearly half –- suffer from dry eyes at least temporarily after the surgery. Because the surgery severs the cornea nerves that stimulate tear production, this has been an obvious and predictable problem.

About 700,000 people have Lasik surgery every year. With about 5% of them having bad results, that translates to about 35,000 people who ended up worse, with pain or with visual disturbances, such as double-vision and halos around lights.

The FDA is now investigating the risks associated with Lasik surgery, but one must wonder where the agency has been for the last 19 years, when the surgical technique was first patented. The first Lasik machine was approved by the FDA about ten years ago.

Lasik is Just Another Industry

The Lasik industry is like any other. Its primary motivation is profits, and this one’s are enormous. The following quote is by Dr. Marguerite B. McDonald, the former Chief Medical Editor of EyeWorld, an international publication for ophthalmologists:

“We are only starting to ride the enormous growth curve of Lasik in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result.”

She clearly implies that the patients’ welfare is of secondary importance to the doctors’ profits! Dr. McDonald is a major player in the field of Lasik surgery. Think of what this implies about the safety of the process and the dishonesty inherent in many doctors doing it.

Of course, this shouldn’t be surprising. Consider all the ophthalmologists who now specialize in only Lasik surgery. Instead of putting their efforts into procedures that might help people at risk of losing their sight, they have opted to do nothing but provide a risky and unnecessary procedure.

Long Term Results May Include Suicide

Long term results are proving to be even worse. Lawsuits are popping up now as a result of problems developing years later.

Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed himself, leaving a note that blamed constant pain from Lasik surgery. He wrote, “I just cannot accept the fact that I’m supposed to live like this.”

Within the industry, there is complete denial of any cause-and-effect between Lasik and suicide. Of course, there have been no studies to see if there’s a connection.

One optometrist, Chistine Sindt, who is also a University of Iowa associate professor of clinical ophthalmology, says that she has seen depression in people with vision problems caused by Lasik. “It’s not just that they lose vision. They paid somebody… who took their vision away.”

Naturally, the Lasik industry explains this sort of thing by saying that the people who become depressed suffered from psychological problems before the surgery. One would think, though, that any doctor whose first interest is in the patient’s welfare would want to err on the side of caution. Instead, though, there has been denial.

Permanent Pathological Changes in All Lasik Patients

In a study published by Cornea in January 2005, it was reported that, of 25 post-mortem Lasik patients, every single one of them had suffered pathological corneal changes that were permanent. There were no exceptions. These patients had died between 3 months and 7 years after their surgeries, and the only determinant for selecting a case for examination was that the person’s visual status prior to the surgery was known.

Corneas Do Not Heal Completely After Lasik

In the September-October issue of the Journal of Refractive Surgery, a report of a study on the healing of Lasik patients reported that most do not achieve anywhere near the quality of structure that’s achieved from most corneal wounds. The relative strength of the Lasik-induced wound’s tissues average only 2.4% of normal tissue. Wounds gotten in an accidental manner typically develop scars with 28.1% the strength of normal tissue.

In the Journal of Refractive Surgery’s April 2007 issue, the authors stated, “The Lasik flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed.”

Lasik patients are left with permanently weakened corneas. This means that they are forever at risk of permanent eye damage from relatively minor injuries. Those who are most at risk of suffering permanent damage as a result of Lasik surgery, people who are involved in highly physical sports or jobs, are the ones who are often targeted by the industry. Clearly, the best interests of the patients are not the doctors’ primary concern.

Potential Damage From Lasik Surgery

Lasik surgery has not been in existence for long, only about ten years. Its long term effects are not yet known, but there are many reasons to be concerned.

There are some indications that the procedure may induce cataracts. Many people, including relatively young ones, have claimed that cataracts were induced by Lasik surgery. There have not, of course, been any studies to see if there’s a connection.

Lasik procedures literally evaporate part of the cornea to produce a smooth surface. This is known to create free radicals and apoptosis (cell death and dismemberment) in the stromal, underlying, structure of the cornea. Free radicals are known to cause tumor growth. It may be decades before we see results of this damage –- or it may be entirely harmless. Only time will tell.

In November 2007, EyeNet Magazine, a publication of the American Academy of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik surgery. Joe McFarland, MD, JD stated, “We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing post-refractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant.”

At least one case of neuropathy to both optic nerves of a patient was noted by the journal, Opthalmology in April 2008. It is surmised that the cause was elevation of intraocular (within the eye) pressure induced by a suction ring device routinely used during Lasik procedures. It resulted in several severe vision defects.

A consistent result of Lasik surgery is that people over age 40 who had been able to see things close to them without glasses suddenly require glasses for reading. They have only exchanged distance-vision glasses for reading glasses.

Lasik surgery changes the cornea’s shape and thickness. As a result, intraocular pressure readings, which are critical for diagnosing glaucoma, become inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.

Do You Want to Take the Risk of Lasik Surgery?

Laser sounds so much safer than a knife, but keep in mind that it cuts as sharply as any weapon. One of the primary processes of Lasik surgery is melting part of the cornea to make it smooth. The result is that even the best possible outcome results in poor healing, leaving all, or nearly all, patients at significantly greater risk of permanent eye damage from injury. Aside from the immediate risks of seriously impaired vision and permanent eye pain, the long term risks are only now coming to light.

References:

LasikDisaster, (http://lasikdisaster.com/studies.htm)

Associated Press, ((http://hosted.ap.org/dynamic/stories/L/…)

Washington Post, ((http://www.washingtonpost.com/wp-dyn/co…)

Columbia Tribune, ((http://www.columbiatribune.com/2008/Feb…)

About the author
* Heidi Stevenson, BSc, DIHom, FBIH
* Fellow, British Institute of Homeopathy
* Gaia Therapy (http://www.gaia-therapy.com)
*
* The author is a homeopath who became concerned with medically-induced harm as a result of her own experiences and those of family members. She says that allopathic medicine is the arena that best describes the motto, “Buyer beware.”
*
* Iatrogenic disease is illness, disability, and death caused by medical practice. It is common, resulting in huge costs to society and individuals. It’s possible – even common – to suffer an iatrogenic illness without realizing its source.
*
* Heidi Stevenson provides information about medically-induced disease and disability, along with incisive well-researched articles on major issues in the modern world, so members of the public can protect themselves.

Awareness of Drug-Induced Eye Toxicity Crucial for Patients, Physicians

Says Public Citizen on WorstPills.org
Article in ‘Drug Safety’ Identifies 62 Drugs That Can Cause Eye Disease

April 1, 2008

WASHINGTON, D.C. – Physicians and patients should be aware of the slew of drugs that can cause eye disease and be diligent in identifying potential adverse effects, Public Citizen writes in a new March posting on its WorstPills.org Web site.

A recent paper published in Drug Safety identifies 62 drugs that can cause adverse reactions to the eye. Public Citizen summarizes the paper’s findings, highlights these reactions and describes how they relate to structures in the eye and certain eye conditions.

The eye is composed of a plethora of different types of cells, and drugs can affect each type. The 62 drugs can cause a host of different eye diseases, including cataracts, glaucoma, eye surgery complications, eyelid and conjunctival diseases, optic nerve diseases and retinal abnormalities. Loss of color vision, blurred and impaired vision, decreased night vision, skin lesions and blindness are just some of the symptoms people who develop these diseases can experience.

While people are aware of the undesirable effects drugs can have on organs in the body, they often don’t consider the potential risks to their eyes.

“The eye is a crucial organ, and it is important that physicians and patients understand the risks associated with certain drugs,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

WorstPills.org includes the full list of implicated drugs cited in the Drug Safety article. Some examples include: chloroquine and hydroxycholoroquine, used to treat rheumatoid arthritis, lupus, amoebae and malaria; the antibiotic linezolid; ethambutol, used to treat tuberculosis; corticosteroids; alpha-1 blockers, particularly tamsulosin; botulinum toxin (Botox); morphine administered intravenously or by mouth; and drugs in the anticholinergic and adrenergic categories.

Just as patients check for drug-induced diseases in other parts of the body when starting new medications, they also should consider newly developed eye symptoms, Wolfe said. Early detection and various eye examinations are crucial, since some conditions, such as retinal damage, are reversible only during the earliest stages of the disease.

Worst Pills, Best Pills is a monthly newsletter available in print and electronic formats through Public Citizen’s subscription Web site, www.WorstPills.org. The site has other searchable information about the uses, risks and adverse effects associated with prescription medications, including all the information contained in Public Citizen’s best-selling book, “Worst Pills, Best Pills.”

WorstPills.org is an unbiased analysis of information from a variety of sources, including well-regarded medical journals and unpublished data obtained from the Food and Drug Administration, that allows Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid years before they were pulled from the market.

LASIK failure toll can be high

SOURCE

FDA to study effects of complications from eye surgery; some blame them for depression, suicide
By Sabine Vollmer

McClatchy-Tribune newspapers

February 25, 2008

RALEIGH, N.C.

Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of LASIK complications and quality of life, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote in an e-mail that the scant clinical data available “failed to suggest significant problems following LASIK surgery.”

But she said the FDA wants a broad and systematic review. She wrote, “We also noted that quality of life issues related to LASIK had not been evaluated consistently, and there were few reports of well-designed studies.”

Frustration and sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, six years after LASIK surgery left him with lasting visual distortions. The surgery was done at a LASIK center in Canada that has since closed.

“If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found.

In the note, Dorrian wrote that there had been other instances when he felt down. “I have other problems like most people do. But this is something else,” he wrote. “As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.”

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don’t think LASIK complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

“There’s no cause and effect,” said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from LASIK.

Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, has encountered the psychological effects that patients experience when they have trouble seeing.

“Depression is a problem for any patient with a chronic vision problem,” she said. But in the case of post-LASIK patients, she said, the depression is compounded by remorse.

“It’s not just that they lose vision,” she said. “They paid somebody [who] took their vision away.”

Dr. Alan Carlson, a laser eye surgeon at the Duke Eye Center in Durham, built his career on correcting the vision of patients at high risk of complications. He said people at risk of depression or anxiety are generally not good candidates for LASIK. He compared them to patients who become depressed after undergoing cosmetic surgery.

“Their motivation and expectations may reflect something they’re missing in their life that they’re not telling you about,” he said.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.

A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

The FDA is also planning a public meeting to discuss experiences with LASIK devices since their introduction to the U.S. market.

Mostly safe, successful

Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or LASIK, is safe and successful in most cases and has become more so with new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that only 2 percent to 3 percent of LASIK patients experience complications.

Some link depression, failed lasik

Patients with impaired sight turn suicidal; surgeons reject any connection

Sabine Vollmer, Staff Writer

Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of lasik complications and quality of life, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote in an e-mail message that the scant clinical data available “failed to suggest significant problems following lasik surgery,” but she said the FDA wants a broad and systematic review. She wrote, “We also noted that quality of life issues related to lasik had not been evaluated consistently, and there were few reports of well-designed studies.”

Frustration and even sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be particularly severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, 6 1/2 years after lasik surgery left him with lasting visual distortions. The surgery was done at a lasik center in Canada that has since closed.

“If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found on his body. “I just cannot accept the fact that I’m supposed to live like this.”

In the note, Dorrian wrote that there had been other instances when he felt down. “I have other problems like most people do. But this is something else,” he wrote. “As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.”

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don’t think lasik complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

“There’s no cause and effect,” said Dr. Steven C. Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from lasik.

In September, The News & Observer reported on complications from lasik, a lightly regulated surgical procedure widely promoted as a quick and painless way to eliminate the need for eyeglasses. But patients across the country and in laser eye surgery hot spots such as the Triangle, where 11 laser eye surgery centers operate, say the physical after-effects can cause or aggravate psychological problems.

Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, Iowa, has encountered the psychological effects that patients experience when they have trouble seeing.

“Depression is a problem for any patient with a chronic vision problem,” she said. But in the case of post-lasik patients, she said, the depression is compounded by remorse.

“It’s not just that they lose vision,” she said. “They paid somebody [who] took their vision away.”

Sindt specializes in treating ectasia, a bulging of the eye that is considered the most severe and rarest lasik complication. She sees a few dozen patients with ectasia; all of them show signs of depression, she said.

Lasik usually safe

Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or lasik, is safe and successful in most cases and has become more so with the introduction of new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that 2 percent to 3 percent of lasik patients experience complications.

But surgeons agree that lasik is unlike a face-lift or even most necessary surgery because it affects a process — seeing — that is essentially a mental function. The eyes focus light, but what a person actually sees depends on how the brain decodes an image. Neurological differences in decoding explain why dyslexics reverse letters and why alcohol consumption can produce double vision.

Although laser eye surgery has been around for years, little research has been done to explore how the ability to see affects how people feel and act. In 2006, the FDA began to look into lasik complications and quality-of-life issues and determined more research was needed. A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

Vision-mind connection

The FDA is also planning an open public meeting this spring to discuss experiences with lasik devices since their introduction to the U.S. market.

A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery.

Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data.

Research that Schallhorn did at the Navy Refractive Surgery Center suggests a relationship between satisfaction after lasik and certain personality traits among patients. Schallhorn declined to provide details. Like the results of the Emory suicide study, his research has not been published in peer-reviewed journals.

But some patients are unequivocal: Lasik complications drove them to contemplate suicide.

In Cleveland, Tenn., Kim Hybarger, 44, a nurse, developed debilitating visual distortions after lasik surgery Dec. 21, 2006. She tried to walk into traffic, cut her throat and starve herself.

“I was filled with anger,” she said. “I felt so hopeless and helpless. I just wanted to die. The way I saw was so frightening.”

Hybarger’s mental state didn’t improve until Ed Boshnick, a Miami optometrist, offered to fit her with special contact lenses.

Sales of the special lenses have increased with the rising number of Americans who had lasik since 2000. The lenses can restore the cornea’s shape and correct visual distortions.

New lenses help

Boshnick is one of a handful of specialists who have had considerable success fitting the lenses. Hybarger is one of about 250 patients with complications from lasik who regularly see Boshnick. About half of them suffer symptoms of depression, Boshnick said.

The new lenses can clear up more than vision.

Hybarger left Miami remembering the moment she first looked through them.

“It was indescribable,” Hybarger said. “It was like the first time I smiled in a year.”

The complete article can be found HERE.
2 New Lenses For Post Refractive Surgery

Optometrists and ophthalmologists that work with post-op LASIK problems have 2 brand new lenses at their disposal.

First, J&J Acuvue OASYS now comes in a brand new 8.8 mm base curve, which fits flat on normal eyes but fits well on surgically flattened RK or LASIK eyes.

Second, SynergeyesPS is the first FDA-cleared hybrid contact lens especially designed for patients with oblate corneas resulting from
refractive surgery.

Singapore halts Lasik surgery after inflammation cases

SCIENCE NEWS

March 14, 2007

A key Singapore eye hospital has suspended Lasik eye-sight correction surgery after a surge in the number of patients suffering from inflammation.

The Singapore National Eye Center (SNEC) halted all Lasik surgeries last week after 17 patients suffered from the Diffuse Lamellar Keratitis inflammation following treatments, according to Ravi Chandran, the center’s spokesperson said on Wednesday.

“SNEC has recently seen an unusual increase in inflammatory reaction in patients after lasik treatment,” Chandran said, adding that the cause of the inflammations is still unknown.

Singapore is trying to establish itself as a medical center for foreigners. Some 200,000 overseas patients seek medical care in Singapore each year, more than half of them from neighboring Indonesia.

Patients who suffer from the Diffuse Lamellar Keratitis inflammation do not experience any pain or discomfort, but may have blurry vision for one to two weeks, Chandran said.

The suspension, which is the first-ever in the Southeast Asian city-state, is expected to at least last until the end of the month, according to Chandran.

New LASIK Glue Sticks

New adhesive composite to improve post-op LASIK safety.
SOURCE

9/15/2012

Stacy Littlechild, a recent graduate in biology, is the lead author of studies that describe a new glue involving fibrinogen, riboflavin and ultraviolet light to improve the safety of LASIK surgery.

A new adhesive composite could improve the long-term postoperative safety of LASIK surgery, according to a recent study in Investigative Ophthalmology & Visual Science.

Researchers at the University of Kansas have developed a glue mixture of fibrinogen and riboflavin that, when combined with ultraviolet light, could be used to further stabilize the surgically induced corneal flap after LASIK. Sealing the flap with this nontoxic biodegradable composite could help to reduce postsurgical risks and complications, they say.

“Although LASIK produces a flap that remains clear and normally lays smoothly on the modified corneal surface, if the eye is hit with blunt force trauma—from an auto airbag or a tennis ball, for example—the flap simply peels open again, resulting in contamination inside the cornea and requiring immediate medical attention, which can include corneal transplantation,” says principal investigator, Gary Conrad, Ph.D., distinguished professor of biology at the University of Kansas.

To test the glue, Dr. Conrad and associates measured its adhesive strength on experimental flaps that were cut into the corneas of dogfish sharks and rabbits. Then the researchers exposed the corneas to UV light to further bind the composite and seal the corneal flap in place.

“The idea is that if you use the glue, you’ll either reduce or alleviate the risk associated with LASIK surgery,” says lead author Stacy Littlechild. “If we can decrease the need for [corneal] transplants by using a glue, then we won’t impede lives as much and protect patients from having future surgeries.”

Littlechild SL, Brummer G, Zhang Y, Conrad GW. Fibrinogen, riboflavin, and UVA to immobilize a corneal flap—conditions for tissue adhesion. Invest Ophthalmol Vis Sci. 2012 Jun 26;53(7):4011-20.

Beta-Blocker Eye Drops Can Cause Serious Adverse Reactions

Public Citizen Reveals on WorstPills.org Web Site

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. – Beta-blocker eye drops, used for treatment of blindness-causing glaucoma, may cause significant adverse effects such as death, heart attack, serious drops in blood pressure, fainting spells and other complications, Public Citizen writes in a new November posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the September 2 issue of The Lancet.

To read the entire press release, click here.

Consumers Often Overdose on Prescription Eye Drops

Public Citizen Reveals on WorstPills.org Web Site

Sept. 1, 2006

WASHINGTON, D.C. – Though many eye drop prescription labels instruct patients to use one or two drops, consumers should only use one drop because there is a lesser risk of overdosing, Public Citizen writes in a new September posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the June 19 issue of The Medical Letter on Drugs and Therapeutics.

The volume of liquid contained in one eye drop varies with the thickness of the solution, the design of the dropper and the way in which the patient uses the dropper to dispense drops. By administering a second drop, consumers could lower the effectiveness of the first drop by flushing it out or increase the risk of having an adverse reaction by allowing the medication in the drops to enter the blood stream.

A human eye can hold up to 10 microliters of liquid at a time, whereas a single droplet from an eye dropper can range from 25 to 50 microliters. The excess medicine has only two places to go – streaming down the patient’s face in harmless, but expensive, tear-like rivulets or through a small duct in the corner of the eye and into the nose, where it is absorbed into the blood and distributed to the rest of the body.

The full story can be read HERE

For information on opthalmic conditions such as eye infection, eye inflammation, increased eye pressure, eyelid infection, and dry eyes, please visit Public Citizen’s Worstpills.org website.

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market.

Fusarium Keratitis — Multiple States, 2006

On March 8, 2006, CDC received a report from an ophthalmologist in New Jersey regarding three patients with contact lens–associated Fusarium keratitis during the preceding 3 months. Initial contact with several corneal disease specialty centers in the United States revealed that other centers also have seen recent increases in Fusarium keratitis. This report summarizes the public health response to date in the United States and provides important prevention messages for contact lens users.

Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and rarely, contact lens use (1–3). An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4–21 per 10,000 soft contact lens users, depending on whether users wear lenses overnight. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York. The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62%. First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. Fusarium keratitis is not transmitted from person to person.  As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in multiple states.  On April 10, this report was posted as an MMWR Dispatch on the MMWR website.

Read more at their website…(http://www.cdc.gov/mmwr).

Bausch & Lomb

Bausch & Lomb recalls second contact lens solution

March 2007 – Bausch & Lomb, which has been struggling to recover from a sweeping recall of its ReNu with MoistureLoc contact lens solution, said on Tuesday it had initiated a recall of certain lots of its ReNu MultiPlus contact lens solution.

The company advises consumers to discard any lens care solution that appears to be discolored. The recalled lots all carry the expiration date “2008 – 03” on the bottle.

Read More
Bausch & Lomb Still Unsure Of Mystery Fungus

The company halted U.S. shipments of its ReNu with MoistureLoc contact lens solution Monday night while the Centers for Disease Control and Prevention investigates 109 reports of infection caused by a fungus called Fusarium in patients in 17 states.

The agency has made no direct link between ReNu and the infections, traced back to June 2005, but a high incidence of the affected people had used the solution.

Bausch & Lomb, which also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, stopped short of pulling the brand, made at its factory in Greenville, S.C., but merchants led by Wal-Mart Stores Inc. began removing it from store shelves Tuesday.

Fusarium is commonly found in plant material and soil in tropical and subtropical regions. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims.

Symptoms can include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye. It is not transmitted from person to person.

In February, Bausch & Lomb stopped shipments of ReNu in Singapore and Hong Kong after a similar spike in fungal infections was reported in contact-lens wearers there. It is partnering with health authorities and researchers to investigate the extent and cause of the outbreak, which also surfaced in Malaysia.

More than 30 million Americans wear contact lenses, and the ReNu brand generated $45 million in U.S. sales last year.

You can read more at the following link:

http://www.cbsnews.com/stories/2006/04/12/health/main1493941.shtml?source=RSS&attr=Health_1493941ource=RSS&attr=Health_1493941

This posting was found on a Yahoo Message board 05/03/06 for Bausch & Lomb:
SOURCE

10:43 ET Bausch & Lomb: CDC updates investigation; more than MoistureLoc appears to be at risk – Baird (BOL) 44.20 -4.55: -Update- Baird says the CDC has updated information on 58 fungal keratitis cases (56 contact lens wearers). Of the 56, 57% used ReNu MoistureLoc, 27% Multiplus, and the rest an unknown ReNu product. Firm notes that the association with MoistureLoc and now MultiPlus is far greater than any other competing solutions (to date, firm has yet to confirm that any fungal infections were associated with the exclusive use of a non-BOL solution), and therefore remain concerned that the entire ReNu franchise — not just MoistureLoc — could be at risk. As a reminder, firm has already removed what they believe are the vast majority of ReNu (including MoistureLoc and MultiPlus) sales from their 2006-07 ests, and therefore are making no changes at present to their model.

Potential intraocular side effects of ocular steroids

Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts.

EyeWorld

February 2006

SOURCE

Long-term LASIK Concerns Expressed

Critical Preop Calculation

Full Article

Sunday, December 17, 2006

Millions of Americans have undergone refractive surgery (RK, PRK, LASIK, LASEK, INTACS, etc.) to reduce or eliminate their need for glasses and contact lenses.

Millions of other Americans receive cataract surgery every year for removal of a cloudy lens. An artificial intraocular lens (IOL) is implanted to substitute for the natural lens.

Now, these two groups of patients are beginning to collide and it’s not very pretty!

Prior to cataract surgery precise measurements and calculations must be performed to determine the appropriate IOL lens power. Measurements include items like the current refractive error and the central corneal curvature. Data is entered into a sophisticated formula using customized computer software. These formulas assume the eye is healthy and has never had previous surgery.

Now, a backstage peek: IOLs are stored in cabinets and organized by different lens powers (+ or – diopters in nearly every power imaginable) just like a shoe store. Miscalculate the IOL power and the patient cannot see clearly afterwards – even if the surgery itself was flawless.

Factors consumers should weigh when eyeing surgery

SOURCE

By Washington PostDec 26, 2006 – 06:42:16 am PST

While results have improved for laser eye surgery patients, experts warn that the decision to have surgery should never be made without careful consideration of the potential risks. Lasik and similar procedures are not approved for patients younger than 18, because their vision has not stabilized.Here are some factors consumers should consider: — Some people complain that although they see 20/20 on the eye chart after surgery, their vision is not as crisp as it was with contacts or glasses. People with large pupils and those who are very nearsighted may develop glare or halos, especially at night. Others may have trouble discerning contrast.

— Serious complications are rare — ranging from about 1 to 2 percent of patients, depending on surgeon experience — but they do occur. Some are permanent.

— If you participate in contact sports, Lasik may not be advisable because a blow to the face could dislodge the corneal flap. PRK, a more painful procedure that involves several days of healing time, may be preferable because there is no flap.

Technology widens eye surgery pool, but skeptics remain

Seeing the big picture

Sun, Dec. 24, 2006

“But not everyone is enamored of the new technology. David Hartzok, an optometrist in Chambersburg, Pa., specializes in treating people with complications from laser surgery. He also directs the Vision Surgery Rehab Network, an advocacy group for patients with post-operative problems.“The people I see coming in today are the products of the new technology, and they’re having the same problems,” such as dry eye, glare, starbursts and blurred vision, Hartzok said. “I do think in general surgeons are more circumspect about the kinds of patients they do and lasers are better.” But that, he said, is no guarantee of a good result.”

Full article

Warning from the BBB and FTC

Lasik eye surgery is one of the newest procedures to correct vision problems. But, before you sign up for the surgery, the Better Business Bureau, along with the Federal Trade Commission, suggests you know the facts.

Many people rely on glasses and contacts to correct their vision, but some find these methods inconvenient, uncomfortable or unattractive.

Read More

More News & Inside Stories from the Laser Eye Surgery Industry:

LASIK, PRK, LASEK, and ICLs

Read More

Study: Some See Stars After LASIK

LASIK surgery might not be the miracle sight cure some patients expect, according to a new study.

Nearly one-quarter to one-third of patients who underwent LASIK surgery reported problems seeing at night, a new study reported.

Read More

The National Institute for Health and Clinical Excellence (NICE) has issued guidance on

Photorefractive (laser) eye surgery:

for the treatment of refractive errors (short and long-sightedness) to determine whether it is safe enough and works
well enough for use. The guidance does not recommend that laser eye surgery should be offered to patients routinely on the NHS, as for most people eye problems can easily be corrected by wearing spectacles or contact lenses.

In summary the guidance states that:

– Current evidence suggests that laser eye surgery is safe enough and works well enough for use in appropriately selected patients.

– Clinicians wishing to undertake laser eye surgery should ensure that patients understand the benefits and potential risks of the procedure. Risks include failure to achieve the expected improvement
in unaided vision, development of new visual disturbances, corneal infection, and flap complications. These risks should be weighed against the risks and any possible inconvenience of wearing spectacles
or contact lenses.

– Clinicians should audit and review clinical outcomes of all patients who have laser eye surgery. Further research will be useful and clinicians are encouraged to collect longer-term follow-up data.

– Clinicians should have adequate training before performing these procedures. The Royal College of Ophthalmologists has produced standards for laser refractive surgery.

Read more at their website: http://www.nice.org.uk/pdf/2006_012_NICE_issues_guidance_on_laser_eye_surgery.pdf

Sensitivity of the NEI Refractive Error Quality of Life instrument to RS outcomes

J Cataract Refract Surg. 2005 Dec;31(12):2313-8.

Nichols JJ, Twa MD, Mitchell GL.

From the full text (you won’t see this in the abstract):

Quote:

One might also predict these 2 groups to report a significant difference in glare. However, the design of the clinical trial for these LASIK patients limited enrollment to those who were unlikely to experience this problem (ie, low to moderate myopia and pupil sizes less than 7.5 mm).”

There is something terribly wrong with this picture. They exclude high myopes and patients with large pupils in their “quality of life” survey in order to make LASIK look good. Some in the industry keep saying pupil size doesn’t matter and others say there’s still debate on whether or not pupil size matters. But if pupil size didn’t matter, why not include patients with large pupils in these surveys?

It’s all just a big cover-up. They know good and damn well pupil size matters.

Low light problems such as glare and halo occur in some 3-5% of patients after PRK or LASIK

The 3 commonest reasons for this are:

Read More

Known Risk Factors for Ectasia

Cataract & Refractive Surgery Today

October 2005

http://www.crstoday.com/PDF%20Articles/1005/CRST1005_F3_Trattler.html

“Ectasia is one of the most feared postoperative complications of LASIK,”

said Dr. Behrens, cornea surgeon and researcher at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.

While its incidence appears to be low, it is a devastating occurrence for patients with healthy eyes who are undergoing an elective surgical procedure,” Dr. Behrens said at the meeting sponsored by the Johns Hopkins University School of Medicine, Baltimore, and Ophthalmology Times. “Importantly, available information indicates we are currently lacking an accurate method to identify patients at increased risk.”

Still Newsworthy

University partners with industry to assist patients injured by Lasik – Read More

Lasik risks understated – Read More

Washington Post Articles – Read More

The American Academy of Ophthalmology says that very short-sighted people “should not have” LASIK eye surgery – Read More

Prevention may be best strategy for managing post-LASIK dry eye – Read More

More LASIK related articles from Ophthalmology Times (Type in LASIK in search box) – Read More

A new study by US researchers reveals that as many as one in five LASIK patients need a second treatment (May, 2003) – Read More

Palmer Awarded Damages After Failed Eye Surgery

A Palm Beach, FL County jury sided with Hall of Fame pitcher Jim Palmer yesterday, finding an ophthalmologist liable for damage to Palmer’s vision and awarding him $890,000.

His attorney, Gary Cohen, said Palmer was talked into a getting a multifocal intraocular lens in his eye that isn’t made for people who work at night. That lens was later taken off the market, Cohen said.

After the cataract surgery, there were signs of retinal tears that should have prompted further examination but were instead ignored and led to a detached retina, Cohen said. Palmer still suffers from vision problems that have affected his ability to work, as many games are held at night.

Undergoing a reattachment surgery was “pretty scary,” Palmer said, not knowing whether he would be able to see when the surgery was over.

The jury awarded $327,000 in lost earnings and $563,000 in past and future pain and suffering.

The full story can be found HERE

LASIK volume up more than 25%, ASCRS survey finds

SOURCE

WASHINGTON — The volume of LASIK procedures grew 26% from 2003 to 2004, according to an annual survey of practice preferences presented here at the American Society of Cataract and Refractive Surgery meeting.

Other notable findings of the survey of U.S. members of ASCRS included an overwhelming preference for acrylic IOLs, a unanimous interest in accommodating IOLs and a near-doubling of the use of clear corneal incisions from 5 years ago.

David V. Leaming, MD, sent his annual survey on general ophthalmic trends to 6,296 physicians; 773 returned the questionnaire. He reported the results of the survey here in a presentation and a poster.

According to Dr. Leaming, in 2004, 62% of survey respondents used topical plus intracameral anesthesia in cataract surgery.

Over a 5-year period, from 1999 to 2004, the use of clear corneal incisions almost doubled, from 40% to 72%, according to survey responses. Surgeons said they prefer a metal blade to a diamond blade by a two-to-one ratio, Dr. Leaming reported.

As in recent years, acrylic IOLs remained the preferred IOL material among respondents, followed by silicone, PMMA and hydrogel. More than half the respondents — 57% — said they prefer a single-piece foldable IOL

For use with ultrasmall-incision cataract surgery in the future, 38% of respondents said an acrylic lens is the most promising IOL, and 29% of respondents said an injectable lens material holds the most promise.

In a change from last year, 61% of respondents said they prefer implanting a clear IOL rather than a blue-light-filtering IOL. In 2003 47% reported preferring clear lenses.

The survey also addressed refractive surgery topics. As noted above, respondents reported an increase in LASIK volume by 26% in the year since the 2003 survey.

Seventy-five percent of respondents said 250 µm is the threshold for the residual stromal bed below which they would not perform LASIK.

Asked about what refractive procedures they were interested in adopting, 84% of respondents said they were not interested in scleral expansion, 49% were not interested in conductive keratoplasty, 54% were not interested in LASEK and 50% were interested in phakic IOL implantation.

Respondents said they charge an average $500 additional to perform customized LASIK over their fee for conventional LASIK.

Dr. Leaming noted that in 2003 respondents said only 9% of patients were offered wavefront LASIK. In 2004, every patient was offered the option of wavefront, he said.

The survey respondents reported an overall post-LASIK ectasia rate of 9%.

Regarding glaucoma, the survey posed a series of scenarios and asked what drug the respondents would prescribe. For first-line therapy in a 45-year-old patient, 60% said they would prescribe prostaglandins if the patient was blue-eyed with no cardiopulmonary complications, and 77% would prescribe prostaglandins if the patient had brown eyes and no cardiopulmonary complications. For a blue-eyed patient with a history of cardiopulmonary complications 83% would prescribe prostaglandins, and for a brown-eyed patient, 94%.

Regarding medical liability, 17% of respondents said they pay a malpractice insurance premium of $10,000 per year; 14% each said they pay $7,500, $12,500 or $15,000.

Will New FDA Approval Spur NSAIDs Interest?

Using NSAIDs during the preoperative period can reduce postop pain and inflammation and can provide better visual outcomes.

Michelle Stephenson, Contributing Editor

Vol. No: 12:06Issue: 6/15/2005

IN LATE MARCH, THE U.S. FOOD AND DRUG ADMINISTRATION approved the new drug application for Xibrom (bromfenac ophthalmic solution 0.09%, Ista Pharmaceuticals) for the treatment of ocular inflammation after cataract surgery. Xibrom will be launched in the United States this summer.

Currently available ophthalmic nonsteroidal anti-inflammatory drugs include three formulations of Acular (ketorolac tromethamine, Allergan), Ocufen (flurbiprofen sodium, Allergan), and Voltaren (diclofenac sodium, Novartis), and these drugs are widely used after both cataract and refractive surgery.

The pre- and postoperative use of NSAIDs can help to ease pain and inflammation and can accelerate the return of visual acuity in cataract surgery patients. Additionally, use of NSAIDs keeps pupils dilated during surgery, which allows for quicker and less traumatic procedures.

“Other indications in cataract surgery include the prophylaxis of cystoid macular edema, control of pain associated with clear-corneal cataract incisions, and the improvement of quality of vision after cataract surgery,” says Calvin W. Roberts, MD, clinical professor of ophthalmology at Weill Medical College of Cornell University, in New York City. “The other main indication for the use of NSAIDs is in refractive surgery to control pain after surface ablation and after incisional corneal surgery. I can’t think of any other class of medications that is effective for doing so many things.”

NSAIDs’ Mechanism of Action

NSAIDs inhibit the metabolic pathways of prostaglandin synthesis, which controls inflammation and pain after both cataract and refractive surgery. Intraoperatively, patients who have been given NSAIDs have less blepharospasm and discomfort.

“With cataract surgery, one of the main advantages of nonsteroidals is that they inhibit the prostaglandin release that causes pupillary miosis, and they are very effective at maintaining mydriasis,” says Eric D. Donnenfeld, MD, an associate professor of ophthalmology at New York University Medical Center, New York City.

Dr. Donnenfeld recently conducted a study to assess the clinical benefit, relative efficacy, and dose response curve of preoperative Acular LS (0.4% ketorolac tromethamine ophthalmic solution, Allergan) as a surgical tool in cataract surgery. He presented the study results at the annual meeting of the American Society of Cataract and Refractive Surgery in Washington, DC.

The double-masked study included 100 patients who were randomized into four groups. Three groups received Acular LS before cataract surgery: three days, one day, or one hour preoperatively. The fourth group received placebo.

The effect of Acular LS on maintaining preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, pachymetry, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, intraoperative complications, and cystoid macular edema were evaluated.

The study found that the maintenance of pupil size, phacoemulsification time and energy, operative time, corneal clarity, postoperative inflammation, and intraoperative and postoperative discomfort was significantly improved with three-day NSAID pretreatment compared to one-day pretreatment, and one-day pretreatment was significantly better than one-hour pretreatment or placebo. In fact, Dr. Donnenfeld says that patients who received Acular LS for three days preoperatively had almost 2 mm more pupillary dilation during cataract surgery compared to placebo.

“In addition, there was a trend toward improved pachymetry on postoperative day one and endothelial cell counts at three months in the three-day pretreatment group relative to placebo. The use of NSAIDs significantly improves patient rehabilitation postoperatively, so that patients see better faster and have fewer postoperative complications,” he says.

According to Henry D. Perry, MD, prostaglandins occur naturally in the eye and are constantly being formed. “Using an NSAID three days before cataract surgery significantly decreases the amount of prostaglandins in the eye. So, when the incision is made, there will be less of an inflammatory response, just because there are fewer prostaglandins in the eye,” says Dr. Perry, who is an associate clinical professor at Weill Medical College.

He also notes that NSAIDs help to lessen patients’ response to painful stimuli because of their anesthetic and analgesic effects. Postoperatively, they are additive to corticosteroids for decreasing inflammation.

NSAIDs have also been found to help patients achieve better contrast sensitivity and better quality of vision after cataract surgery. “The use of nonsteroidals preoperatively and postoperatively will decrease the amount of inflammation that occurs after surgery, and this is directly related to the quality of the vision that the patient achieves,” Dr. Roberts says.

In his recent study, also presented at the ASCRS meeting, 200 patients undergoing routine phacoemulsification were randomized to receive Acular LS along with postoperative steroids and antibiotics, or to receive only postoperative steroids and antibiotics. Macular thickness was measured by optical coherence tomography prior to surgery and one month postoperatively, and contrast sensitivity was measured one month postoperatively. The study found that the incidence of postoperative macular edema was higher in the group that did not use Acular LS and that contrast sensitivity was decreased in the group that did not use Acular LS.

“We concluded that the use of topical NSAID drops can reduce macular edema and improve contrast sensitivity in routine phacoemulsification, and contrast sensitivity is a better indicator of quality of vision than visual acuity after cataract surgery,” he says.

Comparing NSAIDs

Dr. Roberts says that the currently available NSAIDs can be differentiated by potency. Acular and Voltaren are more potent than Ocufen. “In fact, there is really no indication for the use of Ocufen,” he says.

However, although Acular and Voltaren are potent NSAIDs, these drugs have side effects. For example, both Acular and Voltaren sting and burn on instillation. According to Dr. Donnenfeld, diclofenac’s adverse-event profile includes transient stinging and burning in approximately 15 percent of patients with up to 28 percent of patients developing keratitis, and ketorolac has an even higher rate of stinging and burning, with up to 40 percent of patients who use the old formulation experiencing discomfort.

The incidence of burning and stinging has been significantly reduced with Acular LS. “This may sound like a small thing, but when patients use these drops for a long time, stinging becomes a big issue. Acular LS gives us the best of all worlds. It is just as effective as the 0.5% formulation, it is more comfortable, and it is more convenient because it comes in a big bottle,” Dr. Roberts says.

He noted that some refractive surgeons prefer Acular PF (preservative-free) because they want to minimize the amount of preservatives in the eye after cataract surgery. However, he noted that the concentration of preservative in Acular LS is extremely low.

“NSAIDs are safe drugs that have received some bad press, especially Voltaren, because of corneal complications related to the use of the drug topically in dry-eye patients. There is some concern about using NSAIDs in patients with very dry eyes, such as those with keratoconjunctivitis sicca, which is justified. However, for the most part, this class of drugs is very safe for topical use,” Dr. Perry says.

Both Acular and Voltaren are indicated for four times daily dosing for 14 days after cataract surgery to achieve a decrease in postoperative inflammation.

Xibrom

Dr. Donnenfeld was a Phase-III investigator for Xibrom, and he presented results of two Phase III studies at the ASCRS meeting. The studies evaluated the efficacy and safety of Xibrom compared with placebo dosed twice daily for 14 days after cataract surgery with a 14-day follow-up for safety.

The study included 527 patients with a summed (cells + flare) ocular inflammation score of more than three following cataract surgery, in the absence of any anti-inflammatory medication. These patients were randomly assigned to bromfenac or placebo. Treatment was initiated 16 to 32 hours after surgery, and patients were assessed on days three, eight, 15, 22 and 29 after surgery. Ocular and systemic safety was assessed throughout the study.

Of the 527 study participants, 356 were treated with bromfenac, and 171 received placebo. Bromfenac was effective within three days of surgery. In the bromfenac group, 8.4 percent of patients had a summed ocular inflammation score of 0 on day three compared with 1.2 percent of patients in the placebo group. This difference was statistically significant. The proportion of bromfenac subjects with a summed ocular inflammation score of 0 increased at each visit and remained statistically significant through day 29.

According to the study results, 52 percent of patients who received bromfenac had an anterior chamber cell score of 0 on day eight, compared with 30 percent of patients given placebo. On day 15, 76 percent of bromfenac patients achieved this score, compared to 42 percent of placebo patients.

In terms of reduction of post-surgical inflammation, 85 percent of bromfenac patients had marked reduction by day 15 compared to 53 percent of patients given placebo. Additionally, placebo patients had more ocular adverse events.

“We found that Xibrom significantly decreased inflammation at three days, one week, and two weeks after surgery,” he adds.

Xibrom has been approved for twice-daily dosing, and Dr. Donnenfeld believes that this will improve patient compliance. “A topical NSAID with a twice-daily dosing regimen has the potential to enhance treatment compliance while maintaining clinical efficacy,” Dr. Donnenfeld says. “The twice-daily regimen will reduce the frequency of drug exposure and exposure to preservative.”

According to Timothy R. McNamara, PharmD, Xibrom has been approved for twice-daily dosing because of its potency.

“It is a more potent COX-2 inhibitor than other NSAIDs, and very little sting or discomfort is associated with its administration,” he says. Dr. McNamara is director of medical affairs at Ista Pharmaceuticals, Irvine, Calif.

He emphasizes that the FDA required a more stringent endpoint of using a sum score of zero for cells and flare as the primary endpoint in the Phase III studies, and he notes that the researchers achieved that endpoint to a statistically significant level by the 14th day of therapy.

Drs. Donnenfeld and McNamara say that more Xibrom studies will be conducted. Xibrom has not been compared to Voltaren and Acular in the United States, and it has not been studied in refractive surgery patients in the United States.

Xibrom has been used in Japan since 2000, however, and Dr. Donnenfeld says that it has been used in refractive surgery patients there. Dr. McNamara notes that more than 2.7 million patients have received Xibrom in Japan and that it has been compared to other NSAIDs on the market in Japan. “Researchers there have found that it is a much more potent inhibitor of both COX-1 and COX-2, especially COX-2, when compared to diclofenac,” Dr. McNamara says.

Dr. Perry notes that it is twice as potent as Voltaren for inhibiting COX-1 and almost four times as potent for inhibiting COX-2, and COX-2 is the more important enzyme in terms of inhibiting prostaglandin formation.

Addressing Safety Concerns

Some surgeons have questioned the safety of using Xibrom in cataract surgery patients. The oral version of bromfenac sodium was approved by the FDA in 1997, but was voluntarily withdrawn from the United States market approximately a year later following reports of hepatic toxicity when the drug was taken for periods of time exceeding the dosing maximum of 10 days.

However, according to Dr. Donnenfeld, “clinical data from Japan demonstrated that topically administered bromfenac ophthalmic solution 0.9% did not produce plasma concentrations of bromfenac that would be quantifiable using immunofluorescent assay methods with a sensitivity of 50 nanograms/ml. So, the hepatic toxicity potential for topical bromfenac at the doses and duration of therapy for the treatment of post-cataract surgery ocular inflammation is negligible.”

Illuminating Facts About Laser Pointers

As posted in FDA Consumer magazine and obtained from http://www.fda.gov/fdac/features/2005/305_laser.html

May/June 2005

Issue By Linda Bren

Instructors use them to draw attention to information on slide shows. Astronomers use them to point out stars, planets, and other heavenly bodies. And construction workers use them to level and align pipes.

These are all legitimate uses of laser pointers, says the Food and Drug Administration, which regulates lasers and other radiation-emitting devices. But the agency is concerned about the misuse of these potentially dangerous devices and their increased availability for purchase on the Internet.

Laser pointers are misused when they are directed at people or treated as toys. The light energy from a laser pointer aimed into the eye can be more damaging than staring directly into the sun. And the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car, a pilot in a plane, or even a person holding a cup of hot coffee. According to the Laser Institute of America, one woman reported how other mothers she knew bought laser pointers for their children so they could imitate Star Wars characters Luke Skywalker and Darth Vader.

“Laser pointers have become consumer novelty products and promoted as toys,” says Jerome Dennis, a consumer safety officer for the FDA’s Center for Devices and Radiological Health (CDRH). “They’re hazardous as toys and shouldn’t be used frivolously.

“The agency is concerned about the increased availability through the Internet of a variety of laser products that may be illegal or unsafe. Some laser products are intended for use only by professionals or other trained operators. And green laser pointers have the agency particularly concerned. While there are legitimate uses for these green pointers, they may be altered to become more powerful and unsafe if not used responsibly.

“These overpowered pointers may have been modified to emit more radiation than the manufacturer’s original product,” says Lt. Cmdr. Sean Boyd, M.P.H., head of the electronic products branch in CDRH, “and they are not compliant with our standard.” The FDA sets safety standards that must be met before laser products, including pointers, can be legally sold in the U.S. market.

“The potential for injury increases as you increase the power output of the product,” adds Boyd. “Certainly the potential for distraction or flash blindness or startling increases as well when you’re talking about an overpowered green pointer.

“Flash blindness is a temporary loss of vision that occurs when the eye is suddenly exposed to intense light–even from an unintentional sweep of laser light across a person’s eyes. The effect can last from several seconds to several minutes. Recent reports of flash blindness in pilots from laser lights beamed at aircraft have further heightened the agency’s concerns.

The FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent these unsafe products from being sold in the United States.

FDA’s Authority

The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine. And under the Electronic Product Radiation Control Provisions of the act, the FDA regulates both medical and nonmedical lasers such as those used to solder circuits in factories, to scan groceries in a supermarket, or to entertain a crowd with a light show in the night sky.

The FDA may inspect manufacturers of laser products and require the recall of products that don’t comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a display so that the agency can inspect it if possible and take action if required. In 1995, the FDA, working with the Federal Aviation Administration, issued a moratorium that remains in effect on outdoor laser light shows in and near Las Vegas. The action, which affects Clark County, Nev., was taken after airline pilots reported experiencing temporary visual impairment during flights into or out of the county’s three airports.

The FDA requires that labeling on most laser products contain a warning about radiation and other hazards and a statement certifying that the laser complies with FDA safety regulations. The label must also state the power output and the hazard class of the product.

The FDA recognizes four major hazard classes (I to IV), including two subclasses (IIIa and IIIb), of lasers–ranging from those that pose no known hazard to those that pose serious danger if used improperly. The higher the class, the more powerful the laser. Class I laser products, for example, include laser printers and CD players, which are not considered hazardous because the laser radiation is contained within the product.

Class IIIb and class IV laser products are very powerful and permit ready access to the laser radiation, which can cause eye or skin injury. Research and industrial lasers and laser light show projectors fall into these classes. Class IIIb and class IV laser light show projectors may be sold only by or to individuals or firms that have obtained approval from the FDA.

Buyer Beware

In addition to potentially harming your health, some high-powered pointers can damage your wallet, says Dennis. Consumers who purchase an illegal laser product on the Internet–whether knowingly or unknowingly–may lose their money if the product is manufactured outside the United States, he says. “There is a reasonable risk of having a charge laid against your credit card for goods you’re not going to receive because they’re going to be blocked by U.S. Customs and Border Protection.”

What Consumers Can Do

1. Never aim or shine a laser pointer at anyone.

2. Don’t buy laser pointers for your children.

3. Before purchasing a laser pointer, make sure it has the following information on the label:

o a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)

o the manufacturer or distributor’s name and the date of manufacture

o a warning to avoid exposure to laser radiation

o the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

For More Information

If you have questions about a laser product you are considering purchasing or offering for sale on the Internet, contact the FDA’s Center for Devices and Radiological Health at (240) 276-0326.

To report Web sites that you suspect are illegally selling laser products, follow the instructions at www.fda.gov/oc/buyonline/buyonlineform.htm

See additional information about buying regulated products online at www.fda.gov/oc/buyonline/

 

 


video
LASIK Complications
Are Not Being
Reported To The FDA

What is LASIK?
Some Doctors Have
Stopped Doing
LASIK.

LASIK-risks lots of risks.....................................
LASIK Risks!

video
LASIK – Safe?
Effective? Risky?
Deceptive?

Reality LASIK with reality LASIK problems
True LASIK. True
Problems!

LASIK problems often have no plan B fix
No Plan B When
Complications Occur

The Dangers of LASIK - Diane Sawyer ABC
Diane Sawyer, ABC
News: The Dangers of
LASIK.

Per research, LASIK does more damage than people know
Per Research,
LASIK Does More
Damage Than
People Realize.

video
Is LASIK A “Terrible
Idea”?

video
NBC Nightly News:
Health Alert on
LASIK – Part 1

video
NBC Nightly News:
Health Alert on
LASIK – Part 2

 

 



CBS News: The Dark Side Of Eye Surgery

The potential risks and benefits of Lasik eye surgery is under review by the
FDA. Dr. Jon LaPook reports on what happens when the popular procedure yields
unexpected results.



MSNBC Video of The Today Show Special: Is Lasik Eye
Surgery Really Safe?



MSNBC Video of NBC Nightly News Special: FDA Takes
Closer Look at Lasik Surgery



Associated Press Article – April 28, 2008

Analysts say Advanced Medical Optics unhurt by Lasik inquiry.



Wall Street Journal Article – April 26, 2008

While past studies generally have found that 95% of Lasik patients are satisfied
with their surgery, some patients have complained the surgery left them with
damaged eyes and psychological problems.



New York Times – Associated Press Article – April 26,
2008
– In fury and despair, patients harmed by Lasik eye surgery
told federal health advisers Friday of severe eye pain, blurred vision and even
a son’s suicide. The advisers recommended that the government warn more clearly
about the risks of the hugely popular operations.



Morning Star – Dow Jones Wire Article – April 25, 2008

– An FDA panel said Friday that the agency should improve its guidance on laser
vision eye surgery to better inform patients of the surgery’s risks.



WebMD Article – April 25, 2008

Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery.



New York Times – Associated Press Article – April 24,
2008
– Lost in the hoopla of ads promising that laser vision
surgery lets you toss your glasses is a stark reality: Not everyone’s a good
candidate and an unlucky few do suffer life-changing side effects — lost
vision, dry eye, night-vision problems.



Wall Street Journal Article – April 24, 2008

Laser vision surgery has helped millions of people see better without corrective
lenses. But a small number of patients have experienced troubling aftereffects
from the procedure, and the Food and Drug Administration has begun taking a
closer look at their complaints.

  • NBC “Today Show” Coverage:


  • April 24:
    A decade after Lasik surgery
    first became available, unhappy patients like Matt Kosovolos are eager for the
    Food and Drug Administration to hear their grievances. NBC’s Chief Science
    Correspondent Robert Bazell reports.


  • April 25:
    Millions of Americans have
    undergone Lasik eye surgery safely, but some suffer side effects, prompting
    government hearings on the procedure. TODAY’s Dr. Nancy Snyderman comments.
    Disclaimer: The videos on this page are embedded directly from YouTube.
    If YouTube finds that these videos are copyright violation, they will be removed
    from this web page immediately.

 

FDA/CDRH confirms that only (3) LASIK centers have been investigated since the year 2000

In response to Dr. Michael Patterson, the FDA
responds that ONLY 3 laser facilities were inspected from 2000 to 2008.



READ THE LETTER

Corrupt LASIK Surgeons?



SOURCE
June 3rd, 2008

The Natural News: Dr. Marguerite B. McDonald,
the former Chief Medical Editor of EyeWorld, an international publication for
ophthalmologists:” We are only starting to ride the enormous growth curve of
LASIK in this
country. There will be more than enough surgeries for everyone to benefit if we
keep our heads by sharing information openly and honestly and by resisting the
temptation to criticize the work of our colleagues when we are offering a second
opinion to a patient with a suboptimal result.
” Reports That LASIK Leaves About 48% of
Patients With Permanent Dry Eye!

FULL ARTICLE:

Perfect vision without glasses or contacts sounds
wonderful. Before considering having Lasik surgery, though, it would be wise to
ask how many people actually do have good results and how many will suffer bad
effects years after Lasik surgery. The advertisements give the impression that
it’s a perfectly safe — nearly foolproof — procedure. Nothing could be further
from the truth.

Lasik surgery for vision improvement involves cutting a flap in the eye’s
cornea, the clear tissue at the front of the eye, then using a laser to cut and
reshape the corneal tissue under the flap.

According to Dr. Kerry Soloman, who did a study of Lasik’s safety for the
American Society of Cataract and Refractive Surgery, a full five percent have
poor results. These can be worse vision — even blindness — constant eye pain,
blurred vision, dry eyes, and a variety of other distressing visual aberrations.
Interestingly, people who end up with corrected vision but permanent eye pain
are considered successes by the surgeons who do the procedure.

About 48% — nearly half –- suffer from dry eyes at least temporarily after the
surgery. Because the surgery severs the cornea nerves that stimulate tear
production, this has been an obvious and predictable problem.

About 700,000 people have Lasik surgery every year. With about 5% of them having
bad results, that translates to about 35,000 people who ended up worse, with
pain or with visual disturbances, such as double-vision and halos around lights.

The FDA is now investigating the risks associated with Lasik surgery, but one
must wonder where the agency has been for the last 19 years, when the surgical
technique was first patented. The first Lasik machine was approved by the FDA
about ten years ago.

Lasik is Just Another Industry

The Lasik industry is like any other. Its primary motivation is profits, and
this one’s are enormous. The following quote is by Dr. Marguerite B. McDonald,
the former Chief Medical Editor of EyeWorld, an international publication
for ophthalmologists:

“We are only starting to ride the enormous growth curve of Lasik in this
country. There will be more than enough surgeries for everyone to benefit if we
keep our heads by sharing information openly and honestly and by resisting the
temptation to criticize the work of our colleagues when we are offering a second
opinion to a patient with a suboptimal result.”

She clearly implies that the patients’ welfare is of secondary importance to the
doctors’ profits! Dr. McDonald is a major player in the field of Lasik surgery.
Think of what this implies about the safety of the process and the dishonesty
inherent in many doctors doing it.

Of course, this shouldn’t be surprising. Consider all the ophthalmologists who
now specialize in only Lasik surgery. Instead of putting their efforts into
procedures that might help people at risk of losing their sight, they have opted
to do nothing but provide a risky and unnecessary procedure.

Long Term Results May Include Suicide

Long term results are proving to be even worse. Lawsuits are popping up now as a
result of problems developing years later.

Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed
himself, leaving a note that blamed constant pain from Lasik surgery. He wrote,
“I just cannot accept the fact that I’m supposed to live like this.”

Within the industry, there is complete denial of any cause-and-effect between
Lasik and suicide. Of course, there have been no studies to see if there’s a
connection.

One optometrist, Chistine Sindt, who is also a University of Iowa associate
professor of clinical ophthalmology, says that she has seen depression in people
with vision problems caused by Lasik. “It’s not just that they lose vision. They
paid somebody… who took their vision away.”

Naturally, the Lasik industry explains this sort of thing by saying that the
people who become depressed suffered from psychological problems before the
surgery. One would think, though, that any doctor whose first interest is in the
patient’s welfare would want to err on the side of caution. Instead, though,
there has been denial.

Permanent Pathological Changes in All Lasik Patients

In a study published by Cornea in January 2005, it was reported that, of
25 post-mortem Lasik patients, every single one of them had suffered
pathological corneal changes that were permanent. There were no exceptions.
These patients had died between 3 months and 7 years after their surgeries, and
the only determinant for selecting a case for examination was that the person’s
visual status prior to the surgery was known.

Corneas Do Not Heal Completely After Lasik

In the September-October issue of the Journal of Refractive Surgery, a
report of a study on the healing of Lasik patients reported that most do not
achieve anywhere near the quality of structure that’s achieved from most corneal
wounds. The relative strength of the Lasik-induced wound’s tissues average only
2.4% of normal tissue. Wounds gotten in an accidental manner typically develop
scars with 28.1% the strength of normal tissue.

In the Journal of Refractive Surgery’s April 2007 issue, the authors
stated, “The Lasik flap once cut may contribute little to the mechanical
stability of the cornea and probably never completely adheres to the underlying
stromal bed.”

Lasik patients are left with permanently weakened corneas. This means that they
are forever at risk of permanent eye damage from relatively minor injuries.
Those who are most at risk of suffering permanent damage as a result of Lasik
surgery, people who are involved in highly physical sports or jobs, are the ones
who are often targeted by the industry. Clearly, the best interests of the
patients are not the doctors’ primary concern.

Potential Damage From Lasik Surgery

Lasik surgery has not been in existence for long, only about ten years. Its long
term effects are not yet known, but there are many reasons to be concerned.

There are some indications that the procedure may induce cataracts. Many people,
including relatively young ones, have claimed that cataracts were induced by
Lasik surgery. There have not, of course, been any studies to see if there’s a
connection.

Lasik procedures literally evaporate part of the cornea to produce a smooth
surface. This is known to create free radicals and apoptosis (cell death and
dismemberment) in the stromal, underlying, structure of the cornea. Free
radicals are known to cause tumor growth. It may be decades before we see
results of this damage –- or it may be entirely harmless. Only time will tell.

In November 2007, EyeNet Magazine, a publication of the American Academy
of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik
surgery. Joe McFarland, MD, JD stated, “We are also just now learning of some of
the long-term complications of refractive surgery, which are being reflected in
new allegations and lawsuits. For example, some patients are developing
post-refractive ectasia years after the procedure; this condition not only
compromises vision, but also may need to be treated with a corneal transplant.”

At least one case of neuropathy to both optic nerves of a patient was noted by
the journal, Opthalmology in April 2008. It is surmised that the cause
was elevation of intraocular (within the eye) pressure induced by a suction ring
device routinely used during Lasik procedures. It resulted in several severe
vision defects.

A consistent result of Lasik surgery is that people over age 40 who had been
able to see things close to them without glasses suddenly require glasses for
reading. They have only exchanged distance-vision glasses for reading glasses.

Lasik surgery changes the cornea’s shape and thickness. As a result, intraocular
pressure readings, which are critical for diagnosing glaucoma, become
inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.

Do You Want to Take the Risk of Lasik Surgery?

Laser sounds so much safer than a knife, but keep in mind that it cuts as
sharply as any weapon. One of the primary processes of Lasik surgery is melting
part of the cornea to make it smooth. The result is that even the best possible
outcome results in poor healing, leaving all, or nearly all, patients at
significantly greater risk of permanent eye damage from injury. Aside from the
immediate risks of seriously impaired vision and permanent eye pain, the long
term risks are only now coming to light.

Is Lasik surgery worth the risk? I’ll leave that up to you.

Injury
Board: Announces That The FDA Will Add 4 Items To Give More Informed Consent
With
LASIK:



SOURCE
May 13, 2008

Patients harmed by Lasik
eye surgery met with federal health advisers to complain of severe eye pain,
blurred vision and even a son’s suicide. Advisers have asked the Food and Drug
Administration (FDA) to warn the American public more clearly about the dangers
that can arise from the popular surgery in which doctors cut a flap in the
cornea, aim a laser under it and zap to reshape the cornea for sharper sight.
More than 700,000 people undergo Lasik eye surgery annually. While most benefit
by gaining 20-20 vision or better, about one percent or less suffer serious,
life-changing side effects: severe dry eye, glare, the inability to drive at
night, and worse vision. In one case, the results of a botched Lasik eye
surgery, which should never have happened because the patient did not qualify
for the surgery, led the patient to commit suicide.

The
FDA advisers have asked the agency to make the warnings about Lasik clearer by
adding four items. First, they want the agency to add photographs depicting what
people suffering from certain side effects might see, such as the glare that
makes headlights look like bursts of light. Second, they want the warning to
clarify how often patients suffer side effects, like dry eye, since some
surgeons say there is a 48 percent chance of it happening, while others say
there is a 31 percent chance. Third, the advisers want it to be made clearer the
conditions that disqualify people from getting Lasik. Fourth, and finally, they
would like it to be known that if nearsightedness is fixed by the surgery, it is
proven that the patient will need to wear reading glasses in middle age,
something that could be possibly avoided by not participating in the surgery.
While no one is considering restrictions on Lasik, the FDA is joining major
surgeons for a major study next year to better understand which patients have
bad outcomes from the surgery.

Some patients pay dearly in bid for better
eyesight: FDA panel urges clearer warnings about Lasik surgery




SOURCE
April 26, 2008

WASHINGTON — In fury
and despair, patients harmed by Lasik eye surgery told federal health advisers
Friday of severe eye pain, blurred vision and even a son’s suicide. The advisers
recommended that the government warn more clearly about the risks of the hugely
popular operations.

About 700,000
Americans a year undergo the elective laser surgery. Like golf star and famed
Lasik recipient Tiger Woods, they’re hoping to throw away their glasses, just as
the ads say.

Lasik surgery patient David Shell covers his face after speaking at a Food and
Drug Administration hearing in Gaithersburg, Md., Friday, on Lasik surgery.
And while the vast majority benefit — most see 20-20 or even better — about
one in four people who seeks Lasik is not a good candidate. A small fraction,
perhaps 1 percent or less, suffer serious, life-changing side effects: worse
vision, severe dry eye, glare, inability to drive at night.

“Too many Americans
have been harmed by this procedure, and it’s about time this message was heard,”
David Shell of Washington, D.C., told the Food and Drug Administration’s
scientific advisers before their recommendation that the FDA provide clearer
warnings. Shell held up large photographs that he said depict his blurred world,
showing halos around objects and double vision, since his 1998 Lasik.

“I see multiple
moons,” he said angrily. “Anybody want to have Lasik now?”

Colin Dorrian was in
law school when dry eye made his contact lenses so intolerable that he sought
Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye
and pupil size should have disqualified Dorrian, but he received Lasik anyway —
and his father described six years of eye pain and fuzzy vision before the
suburban Philadelphia man killed himself last year.

“As soon as my eyes
went bad, I fell into a deeper depression than I’d ever experienced, and I
couldn’t get out,” Gerard Dorrian read from his son’s suicide note.

Matt Kotsovolos, who
worked for the Duke Eye Center when he had a more sophisticated Lasik procedure
in 2006, said doctors classify him as a success because he now has 20-20 vision.
But he said, “For the last two years I have suffered debilitating and
unremitting eye pain.”

The testimonies
illustrated that a decade after Lasik hit the market, there still are questions
about just how often patients suffer bad outcomes from the $2,000-per-eye
procedure.

But one thing is
clear, said Dr. Jayne Weiss of Detroit’s Kresge Eye Institute, who chairs the
FDA advisory panel: “This is a referendum on the performance of Lasik by some
surgeons who should be doing a better job.”

The FDA advisers — a
group of mostly glasses-wearing eye doctors — recommended that the agency make
more clear the warnings it already provides for would-be Lasik patients:

– Add photographs that illustrate what people suffering certain side
effects actually see, such as the glare that can make oncoming headlights a huge
“starburst” of light.

– Clarify how
often patients suffer different side effects, such as dry eye. Some eye surgeons
say 31 percent of Lasik patients have some degree of dry eye before surgery, and
it worsens for about 5 percent afterward. Other studies say 48 percent of Lasik
recipients suffer some degree of dry eye months later.

– Make more
understandable the conditions that should disqualify someone from Lasik, such as
large pupils.

– And spell out
that anyone whose nearsightedness is fixed by Lasik is guaranteed to need
reading glasses in middle age, something that might not be needed if they skip
Lasik.

That’s a big reason
why Weiss, the glasses-wearing ophthalmologist, won’t get Lasik even though she
offers it to her patients.

“I can read without my
glasses and … operate without my glasses, and I love that,” she said. “The
second aspect is I would not tolerate any risk for myself. … Does that mean
Lasik is good or not good? It means Lasik is good but not for everyone.”

Lasik is marketed as
quick and painless: Doctors cut a flap in the cornea — the eye’s clear covering
— aim a laser underneath it and zap to reshape the cornea for sharper sight.

The FDA agrees with
eye surgeons’ studies that only about 5 percent of patients are dissatisfied
with Lasik. What’s not clear is exactly how many of those suffer lasting severe
problems and how many just didn’t get quite as clear vision as they had
expected.

The most meticulous
studies come from the military, where far less than 1 percent of Lasik
recipients suffer serious side effects, said Dr. David Tanzer, the Navy’s
Medical Corps commander. That research prompted Lasik to be cleared last year
both for Navy aviators and NASA astronauts.

No one’s considering
restrictions on Lasik — but the FDA joins eye surgeons for a major study next
year to better understand who has bad outcomes.

 

 

News Stories
Related to April 2008 FDA Ophthalmic Panel Meeting

 

YouTube Presentations of Hurt LASIK Patients

http://www.youtube.com/profile_videos?user=FDALASIKHearingVideo&p=v

CRS Today: Summary of Hurt LASIK Patients


http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.php

Slides of Damaged Patients/Presentations


http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-4353s1-00-index.html

Shows the FDA’s text version “Summary Minutes” of speakers


http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4353m1.htm

Patient Advocate, Dean Andrew Kantis, Challenges The FDA To Turn In ALL LASIK Patient Complaints:


http://www.youtube.com/watch?v=pTAHDLAwKkw&feature=related

April 25th, 2008: FDA Emergency LASIK Panel Discussion Reports of Dissatisfied LASIK Patients:


http://www.crstoday.com/PDF%20Articles/0608/CRST0608_08.pdf

What is LASIK & Why Did The FDA Call For An Emergency FDA Panel On April 25th, 2008:

http://www.LASIKNewsWire.com

CBS NEWS: Katie Couric Talks About The Problems With LASIK Elective Eye Surgery:


http://www.cbsnews.com/sections/i_video/main500251.shtml?id=4047764n

CBS Interviews Hurt Patients Describing LASIK Results:
http://www.cbsnews.com/stories/2008/04/23/health/main4038420.shtml?source=related_story

 

FDA Is Taking A Second Look At LASIK After 10 Years of Complaints:

http://video.ap.org/v/Legacy.aspx?partner=en-ap&g=ea31a1c3-47f6-4f79-b7b5-88b60b7d2b61&t=s60&p=enapus_enapus&&f=CAMOD

 

WebMD: Experts Advise NEW WARNING For LASIK:
http://www.webmd.com/eye-health/news/20080425/experts-advise-new-warnings-for-LASIK?src=RSS_PUBLIC

Alternatives To PERMANENT LASIK Surgery That You May Want To Consider:
http://www.cnn.com/2008/HEALTH/04/30/LASIK.alternatives.ap/index.html

Dallas, TX News:
LASIK Is Causing Suicides & Permanent Dry Eye Far Worse Than Contact Lenses:


http://www.dallasnews.com/sharedcontent/dws/fea/lifetravel/stories/DN-nh_LASIK_0520liv.ART.State.Edition1.464cd52.html

The
Public Has The Right To Know The Truth About LASIK:
http://capecod.injuryboard.com/medical-malpractice/LASIK-and-the-Patients-Right-to-Know-.aspx?googleid=237642

FDA PANEL Is Asked: “Is The 95% Success Rate
Misrepresented?”
http://recent-business-news.com/data/articles_b17/idb2008.04.26.07.16.42.html

FOX NEWS: LASIK Now Under FED Scrutiny:
http://www.foxnews.com/video2/video08.html?videoId=6bdf68be-7048-4a62-8170-1e497251815c&sMPlaylistID=

NEW YORK TIMES: More Bad News For LASIK Doctors:
http://thelede.blogs.nytimes.com/2008/04/25/more-bad-news-for-the-LASIK-business/?hp

GOOGLE NEWS: FDA Takes Closer Look At BAD LASIK Results:
http://ap.google.com/article/ALeqM5hm4_Y2gN7uuJFU9yGiiiwV0BWDagD90936V83

CNN MONEY: LASIK is NOT Safe:
http://money.cnn.com/news/newsfeeds/articles/apwire/a0bb852cc268d5042e965b7a05771ee4.htm

FORBES: The FDA Examines “Quality of Life” of LASIK Patients:
http://www.forbes.com/forbeslife/health/feeds/hscout/2008/04/25/hscout614914.html

CNN WARNS: FDA Takes Closer Look At Patients Complaints:
http://edition.cnn.com/2008/HEALTH/04/24/LASIK.surgery.ap/index.html

WASHINGTON POST: LASIK Patients Describe Complications At FDA Hearing:
http://www.washingtonpost.com/wp-dyn/content/article/2008/04/25/AR2008042502061.html?hpid=topnews

MSNBC WARNS: FDA Examines Blurred Related Vision Problems:
http://www.msnbc.msn.com/id/24277759/

CBS WARNS: The FDA Wants To Take Another Look At The SAFETY of LASIK Surgery:
http://cbs3.com/health/LASIK.eye.surgery.2.707855.html

http://www.cbc.ca/consumer/story/2008/04/24/LASIK-panel.html

NEW YORK TIMES: Economy Slows And So Does LASIK Eye Surgery:
http://www.nytimes.com/2008/04/23/business/23LASIK-web.html?hp

ABC NEWS: Lisa Stark Reports on the BLURRY OUTLOOK OF LASIK SURGERY:

http://abcnews.go.com/Health/BeautySecrets/Story?id=4665779&page=1

YAHOO BUSINESS: DANGERS OF LASIK EYE SURGERY:

http://biz.yahoo.com/ap/080423/LASIK_problems_fda.html?.v=1

New York Times Reporter, Abby Ellin Warns: “TROUBLING EFFECTS OF LASIK SURGERY…”
http://www.projo.com/health/content/lb_LASIK_surgery_nyt_04-13-08_QM9BURH_v15.e092da.html

REUTERS Warns Public About LASIK Quality Being Investigated:


http://www.reuters.com/article/healthNews/idUSN1761471320080317?feedType=RSS&feedName=healthNews

MSNBC Warns Public About LASIK Quality Being Investigated:
http://www.msnbc.msn.com/id/23689210/

YAHOO Warns Public About LASIK Quality Being Investigated:


http://news.yahoo.com/s/nm/20080317/hl_nm/dc_LASIK_fda_dc_1

New York Times Warns Public About Post LASIK Quality of Vision Problems:


http://www.nytimes.com/2008/03/13/fashion/13SKIN.html?_r=1&pagewanted=1&ei=5070&en=01ec95cbca07e3e8&ex=1206158400&emc=eta1&oref=slogin

Chicago Tribune Warns Public That LASIK Failure Rate CAN Be High:


http://www.chicagotribune.com/news/chi-LASIK_25feb25,0,7016699.story

The North Carolina Observer Warns Public That LASIK Could Lead To Suicide:
http://www.newsobserver.com/150/story/920341.html

“The Grey Sheet” Warns Public About LASIK Quality Being Investigated:


http://www.thegraysheet.com/fdcreports/story/search/submitSearch.do?doClear=true&subsNum=&publications=all&query=LASIK+&find_button.x=20&find_button.y=1

Did Army Surgeon, Scott Barnes, give a misleading testimony at the Emergency FDA LASIK hearing?


http://www.lasikcomplications.com/lasik-prk-refractive-surgery-in-the-military.html

 

 

Hurt
from LASIK
surgery? Register for free to

LASIKSugeryWatch.

 

It
is vital that patients who have had poor outcomes
from refractive surgery be represented as a group with a voice by a patient
advocacy organization such as LSW.
This has never been done before and the time is right to do it now.

http://www.lasiksurgerywatch.org

 

Stem Cell Cornea Fix: Better Vision May Be In Your Own Eyes PDF Print E-mail
Researchers Use Stem Cells From Patients’ Own Eyes to Restore Sight


ABC NEWS report June 23, 2010

More than 1.2 million Americans suffer cornea damage from
injuries and more than 40,000 people a year undergo cornea transplants to repair
otherwise irreversible eyesight damage, according to the American Academy of
Ophthalmology.

But now, a new study suggests that many who suffer corneal
damage by chemical burn may successfully restore their sight with transplants
from their own eye stem cells.

Researchers in Italy studied a technique to repair damaged
corneas by using patients’ own unscathed limbal stem cells — found at the edge
of the cornea — to grow new tissue that was then grafted into the patient’s own
eyes. The experiment was tried on 112 patients with corneas damaged by chemical
burns. It was successful in 78 percent of patients, according to researchers,
who followed the patients for 10 years after the procedure.



READ THE FULL STORY

 

Side effects continue to plague LASIK patients PDF Print E-mail

Now, as the FDA investigates, one expert
admits, “We screwed up”



SOURCE

By Abby Ellin

iStockphoto/Salon

The other day I got a
prescription for eyeglasses. This is not newsworthy in itself except for one
thing: More than two and a half years ago I had Lasik (laser-assisted in situ
keratomileusis), specifically so I could toss away the spectacles I wore for
near-sightedness. I knew that eventually I would need reading glasses, but I
would, I was assured, be able to see long-distance for a long time.

Problem is, I can’t.

Not only is my vision blurred,
but as I wrote in a

2008 article for the New
York Times
, I still see halos, and not the kinds with angels
attached. It takes a good 10 minutes for my eyes to adjust to dimly lit rooms.
My eyes are scratchy and as dry as the desert. Yes, before I got the surgery I
signed an “informed consent” saying I understood all the possible side effects,
but I certainly never knew that they might last indefinitely, and that they
would be more than “annoying,” as my doctor promised. But nearly three years
later, they are still here. And while I could get an “enhancement” — that’s
industry parlance for another surgery to correct errors — frankly, the only
thing I want near my eyes is mascara.

According to the American
Society of Cataract and Refractive Surgery, most of the 13.6 million people in
the United States who have had Lasik surgery since the first lasers were
approved by the FDA in 1998 are pleased with the results. But others have
experienced similar, if not worse, problems than I have.

Indeed, the estimated $2.5
billion industry has recently come under fire for its failure to acknowledge
potential risks. Last spring, the FDA inspected about 50 Lasik facilities and
found that many had no system in place for collecting and transmitting data to
the FDA on patients’ reports of post-surgical “adverse events.”

And in August, Consumer
Reports Health released the results of a survey, which found that 55 percent of
Americans who’ve had laser vision correction surgeries are still wearing glasses
or contacts some of the time. Fifty-three percent experienced at least one side
effect within the first four weeks of the surgery; 22 percent of patients
experienced them six months after surgery, especially dry eyes, halos, glare and
starbursts around lights.

Still, the American Society of
Cataract and Refractive Surgery emphasizes that Lasik surgery, which can cost up
to $5,000, has a 95.4 percent patient satisfaction rate, based on an analysis of
research worldwide from 1996 to 2008, said John Ciccone, a spokesman for the
organization. The researchers evaluated 19 studies involving 2,022 patients that
specifically addressed patient satisfaction.

“Based on everything we know
from the literature, and everything I know from any other elective procedure,
Lasik eye surgery is the most successful elective procedure performed,” said Dr.
Kerry Solomon, a cataract and refractive surgeon in Charleston, S.C., and a
co-researcher on the study.

The experience of patients
like Jeremy Fox, 26, a college student in Rockford, Ill., who got Lasik about
four years ago, seem to support this assessment. Getting the procedure, he said,
was one of the best decisions he has ever made. While he does experience some
starbursts, he said “it’s not bothersome at all.”

But the FDA and others are
taking note of what they call “quality of life” issues. In October, the FDA, the
Defense Department and the National Eye Institute announced in October a
three-year effort to assess adverse effects of Lasik. The effort will involve
gauging how many active-duty military patients at the Navy Refractive Surgery
Center in San Diego suffered post-surgical eye problems, and a series of
national, multi-center clinical trials that will study the impact on quality of
life following Lasik surgery in the general population. In addition, the FDA has
reopened a public docket to receive comments through Nov. 15.

“We noted that there was
little consistent evaluation of the issues,” said Mary Long, an FDA spokeswoman,
about the reasons for why the study was initiated.

Erik J. Rupard, a doctor and
clinical researcher with the U.S. Army, is among those who think such scrutiny
is necessary. “Lasik is the Tiger Woods of medical procedures: deeply and
demonstrably flawed, but so many people love it that those few of us who speak
ill of it are dismissed as cranks and/or loonies,” he wrote in an e-mail
message. “I saw lots of dry-eye complications in soldiers in Iraq who had
undergone the procedure ostensibly because contacts are too unsafe in that dusty
environment, and yet the Department of Defense has done no controlled studies to
look at the cost — human and otherwise — of these post-refractive issues. I am
a clinical researcher, and I know that Lasik, a cosmetic procedure, has never
been subjected to the pre- or post-marketing scrutiny that we put even
lifesaving drugs through.”

Surf the Web and you can find
dozens of stories from people who have had post-Lasik difficulties: dry-eye,
halos, glare. Some complications have resulted in corneal transplants. Over the
last few years patient activists have bombarded the FDA with anti-Lasik e-mails,
complaints and petitions.

Among them is John Hoge, 39, a
businessman in Port Jefferson, N.Y., who suffered from night glare and halos and
regrets not choosing the “zero risk option” of corrective lenses. A few years
ago he got some experimental contact lenses that have largely taken care of the
glare issue. They are expensive, he added, and are not covered by insurance.

While the FDA’s recent efforts
have given some patient activists a modicum of peace, many do not feel it is
enough. “By not inspecting every Lasik facility in this nation, how is the FDA
to know if Lasik doctors are compliant?” said Dean Andrew Kantis, 40, a jet
salesman in Fort Lauderdale, Fla., who has experienced double vision,
starbursts, halos and dry eyes since getting Lasik in 1999, and operates the Web
site
LifeafterLasik.com
.

Some experts believe the FDA
should have taken more care when the first lasers were approved in 1998. “We
screwed up,” said Morris Waxler, a former branch chief of the FDA’s Center for
Devices and Radiological Health Office of Science and Technology from 1995 to
1999. “You know how some drugs have a black box warning — it’s dangerous
because of this, this and this — we could have done something comparable to
that. We should have looked at the worst-case impact on patients, rather than
just the very good outcomes we saw in the clinical trials.”

Larry Pilot, a former
associate director for compliance in the FDA’s bureau of medical devices, and
currently a lawyer practicing food and drug law in Arlington, Va., agreed. “It
appears that information to provide adequate informed consent was not sufficient
for all prospective patients about occasions where a bad outcome could result,”
he said. “The present dissatisfaction rate of 5 percent is very high. Personally
and professionally, I am very disappointed in the FDA.”

Spokeswoman Long refutes the
notion that the FDA was errant. “The FDA has reviewed safety and effectiveness
information included in the manufacturer’s applications for approval,” she wrote
in an e-mail message. “We found them to be safe and effective when used as
indicated and will continue to monitor their safety and effectiveness, in
addition to taking necessary and appropriate steps to protect the public
health.”

Timothy A. Ulatowski, director
of the FDA’s Office of Compliance at the Center for Devices and Radiological
Health, sent out letters to Lasik ambulatory facilities last May reminding them
that all risks must be mentioned in every Lasik advertisement online, in print,
radio or TV.

“As part of our ongoing review
of Lasik and its impact on public health, we continue to look at various aspects
of Lasik advertising and how we can better improve public health,” said Long.

Still, an informal online
search showed dozens of doctors’ Web sites that do not mention risks or side
effects.

As for the new study, Larry
Pilot is not impressed. “The FDA is beginning to do what should have been done
10 years ago,” he said. “The bottom line here is that upwards of scores of
thousands of human eyes have been irreversibly damaged unnecessarily.”

Dr. Solomon disagreed,
maintaining that the FDA clinical trials on Lasik lasers were “rigorous” and
“well-performed.” “I think the FDA did an outstanding job at evaluating the
technology,” he said. “And the technology and procedure since approval have only
gotten better.”

As for me, if I had to do it
all over again I wouldn’t. But hindsight, alas, is 20-20.


Abby Ellin is the
author of “





Teenage Waistland: A Former Fat Kid Weighs in on Living Large, Losing Weight and
How Parents Can (and Can’t) Help



.” She lives,
works, and tries to see in New York City.

Updated February 25, 2010

Former FDA Chief of Medical Devices, Morris Waxler, PHD, Warns Public About Dangers of
LASIK – Aired February 25th, 2010 on Good Morning America


Leave it to the FDA to deny that they ‘MESSED UP’. Mr. Waxler admitted 10 years after his retirement what most LASIK casualties have been trying to say since the late 1990s. The FDA continues to downplay the risks further allowing more people to get damaged from this procedure – when is enough enough? At least Mr. Waxler has taken his time to actually talk to damaged patients on a personal level (myself included), which is more than I can say for the FDA. I commend Mr. Waxler for his honesty.


Could LASIK Lead to ‘Permanent Vision Problems’?


FDA Must Stop ‘Epidemic of Permanent Vision Problems,’ Former
Proponent Says



SOURCE


September 22, 2010

A former Food and Drug Administration official who helped get the
vision correction surgery LASIK approved back in the 1990s but later spoke out
against the procedure is taking his concerns directly to current regulators at
the FDA.

Morris Waxler, who is now an independent regulatory consultant,
filed a citizens petition today urging the agency to take steps to stop what he
calls “the epidemic of permanent vision problems” caused by LASIK.

Waxler’s petition implores the FDA to take actions to crack down
on the procedure, including issuing a public health advisory that warns the
public about the dangers associated with LASIK and implementing stricter
controls over LASIK device manufacturers and practitioners who perform the
surgery.

In the petition, Waxler included data that he said were evidence
that “LASIK causes persistent vision problems with an overall success rate of
less than 50 percent; a failure rate of more than 50 percent.”

Waxler said his change of heart came about after he retired from
the FDA in 2000. He started getting complaints from people who suffered serious
side effects from the procedure, including seeing halos, impaired night vision
and excessive glare.

He was surprised when he looked back at the data presented when
LASIK was undergoing the approval process in the late 1990s.

“When I looked back at that data, there was a tremendous
consistency that show these problems exist in about 18 percent of people who had
LASIK, most of them after I left the FDA,” he said.

Some doctors, however, say while they agree with the estimate
that thousands of people have had problems after having LASIK surgery, they
stress that the vast majority of people are very happy after having the
procedure done.

“Ninety-nine percent of people who have had LASIK have excellent
results,” said Dr. Robert Cykiert, clinical associate professor of ophthalmology
at NYU Langone Medical Center. “Millions of people have had the procedure done
with a high success rate.”

Doctors, Patients Say LASIK Procedure Is
Safe and Effective

One of those satisfied patients is Andy Ng of Long Island,
N.Y.

Ng had LASIK in 2004. He decided to go through with the
procedure because he got tired of spending hundreds of dollars on glasses that
needed special lenses and would get banged up because of his participation in
sports. He also found contact lenses cumbersome and time-consuming.

He said he already knew about the side effects before he went
in for the surgery.

“I knew for a fact I was going to have halos at night,” Ng
said. He added that aftewards, the halos didn’t make much of a difference for
him.

“I have no other problems, such as floaters, dry eyes, etc.,”
he said.

Doctors stress that LASIK is no different from any other
medical or surgical procedure.

“We always would like to have any medical procedure or
surgical procedure that works 100 percent of the time, but that doesn’t exist,”
Cykiert said.

“Complications do happen, but it’s rare, and often, we’re not
sure why,” said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai
School of Medicine.

Doctors also say that even if a patient is an ideal candidate,
the surgeon is very skilled and the equipment is top-of-the-line, problems can
still occur, so it’s difficult to predict whether someone will suffer from LASIK-associated
side effects.

Communication, Information Vital to
Minimizing LASIK Risk

Not everyone is a candidate for LASIK, and doctors say it’s
important for prospective patients to understand that. People with vision that
continues to get worse, extremely poor vision, certain characteristics of the
cornea and some diseases may not be suitable candidates for the procedure.

“Doctors need to take time with a patient and get all the
information they need,” Asbell said. “Doctors also need to learn what the
patient’s expectations are. If a person wants 20/15 vision, they may not be the
best candidate.”

Experts also say there are still things about LASIK that they
just don’t know.

“It’s very hard to quantify these side effects, such as
determining how to measure how bad things like glare and halos are,” Asbell
said. “It’s hard to pin down risk factors that differentiate the people who have
problems from the ones that don’t so we can try to learn more.”

“There are many things we still don’t know about the cornea,
such as physiology and variability in structure, so we don’t know why some
patients bounce back and others don’t,” Cykiert said.

Cykiert also said that the thousands of people who have
problems have a legitimate reason to complain to the FDA, and that information
they provide can be helpful for everybody.

“That’s how we’re going to make the procedure safer and
better,” he said.

And that’s also how there may eventually be more people like
Andy Ng, who has no complaints about his LASIK experience.

“The procedure is one of the best things out there for the
eyes,” he said.

ASCRS President Denies Accusations of Former FDA LASIK Chief


SOURCE

In a scathing three-page letter to R. Doyle Stulting, MD, PhD, president of
the American Society of Cataract and Refractive Sugeons (ASCRS), Morris Waxler,
PhD, the head of the Food and Drug Administration (FDA) branch responsible for
reviewing data on LASIK between 1996 and 2000, accused the ophthalmic
organization of blatantly ignoring several of the risks involved in PRK and
LASIK procedures.

In the letter dated May 7, 2010, Dr. Waxler, who recently said the FDA’s
approval of LASIK devices was a mistake, specifically criticizes a proposed
ASCRS phase 2 keratectasia trial, claiming it is unethical and puts patients at
risk of post-surgical corneal failure, induces corneal thinning and bulging, and
increases the likelihood of other permanent LASIK complications.

“The ASCRS Phase II keratectasia trial proposes doctor-induced (iatrogenic)
injury in vulnerable patients in order to study iatrogenic insult, instead of
mitigating thinning and bulging of the cornea by not performing LASIK and by
determining how to stabilize corneas already damaged by LASIK,” writes Dr.
Waxler, who goes on to say he will do everything he can to block the approval of
such a study.

In support of his claims, Dr. Waxler cites several clinical reports that, among
other statistics, say 15% to 30% of LASIK patients suffer from eye pain, glare,
halos, dry eyes, night vision and other problems, and 1% of LASIK patients have
keratectasia.

Dr. Waxler also accuses the FDA of being “complicit with LASIK manufacturers,
ASCRS, and others in minimizing multiple permanent vision complications.” He
asked for Dr. Stulting’s cooperation in helping to eliminate unnecessary LASIK
through more transparency about the short-term “wow” effects versus the reality
of permanent eye injury.

In a response letter dated Sept. 20, 2010, Dr. Stulting broadly denies all of
the claims and accusations made by Dr. Waxler, calling his view of LASIK
“misinformed, unsupported by evidence, and lacking in balance and perspective.”

“LASIK was first approved by the FDA on your watch, following all the required
FDA protocols and guidance documents created to measure safety and
effectiveness. In fact, laser vision correction is one of the most studied
elective surgical procedures, with 7,830 patients representing 16,502 eyes in US
FDA clinical trials from 1993 to 2005 – not to mention more recent submissions
to the FDA and thousands of other patients reported in the published
literature. The FDA review process is more stringent than that of any other
country in the world,” he stated.

Addressing Dr. Waxler’s accusation that the ASCRS Phase II keratectasia trial
poses a danger to patients, Dr. Stulting called the assertion “plainly wrong,”
saying Dr. Waxler does not have access to the protocol he references, making it
impossible for him to make a responsible, meaningful comment. “Your negative and
accusatory comments are inappropriate, misleading, and without foundation,” he
said.

Dr. Stulting also said the statistics Dr. Waxler cited were inflated and
inconsistent with existing data. For example, the report that Dr. Waxler’s used
to claim that at least 1% of LASIK patients have keratectasia actually gave the
rate of 0.66%, and even that is the highest estimate in the literature, Dr.
Stulting said. Published estimates of its incidence actually range from 0.0004%
to 0.66%, he said.

Dr. Stulting also accused Dr. Waxler of manipulating data by referencing the
incidence of keratectasia outside of the United States, and on another occasion
referencing the results of LASIK treatments with a laser designed more than 20
years ago that is not commonly used in the United States today.

“In summary, your letter is filled with false statements, incorrect citations of
the published literature, references that do not fairly represent the existing
literature, mischaracterization of a study protocol you have never seen,
incorrect reference to outcomes of PRK as if they were for LASIK, citation of
results for a laser designed two decades ago as if were representative of modern
lasers, mischaracterization of results from older lasers as “better than most,”
reference of a graph that does not exist in the reference you cite, and
misrepresentations of the actual performance of modern excimer lasers for the
correction of refractive errors,” Dr. Stulting said.

Given Dr. Waxler’s experience and Dr.
Stulting’s influence with industry, I’d be more inclined to believe Dr. Waxler!

 

$5.6 million against Kevin Niksarli, M.D., for LASIK malpractice PDF Print E-mail


SOURCE

Johnson Devadas and Saramma Devadas v. Kevin
Niksarli, M.D., Manhattan LASIK Center, PLLC, and NewSight Laser Center, PLLC

New York County, Supreme Court of the State of New York
Index # 107637/07

Manhattan, NY (PRWEB) June
14, 2009 — On Wednesday, June 10, 2009, a jury in New York City returned a
verdict of nearly $5.6 million against Kevin Niksarli, M.D., for LASIK
malpractice. The verdict consisted of an award of: $2,360,000 for the patient’s
loss of income; $3,100,000 for the patient’s pain and suffering, including loss
of life’s enjoyment; and $120,000 for the patient’s wife’s claim for loss of her
husband’s services and consortium. This is the second largest verdict ever for
LASIK malpractice.

The lawsuit, Devadas v. Niksarli, Index No. 107637/07 (Supreme
Court New York County), was commenced on May 31, 2007. The trial began on May
20, 2009, and lasted 10 days. The jury of three men and three women deliberated
for 2 and one-half days. The Honorable Doris Ling-Cohan presided over the trial.

The plaintiff, Johnson Devadas, is a pharmacist who lives and
works in Queens, New York. On March 25, 2004, Dr. Niksarli concluded that Mr.
Devadas was a suitable candidate for LASIK surgery. However, plaintiff’s medical
expert testified that he was not. Paul Donzis, M.D., and ophthalmologist and
cornea specialist from Los Angeles, California, testified that prior to the
elective surgery, the plaintiff had a contraindication to LASIK surgery, forme
fruste keratoconus. Dr. Donzis explained that forme fruste keratoconus was a
stable or abortive form of keratoconus that would not likely progress without
LASIK surgery. However, as a result of the LASIK surgery, it caused the cornea
to develop post-LASIK ectasia, or a progressive thinning of the cornea. Ectasia
causes problems with visual quality, including blurriness, halos, double vision,
glare, contrast sensitivity, starbursts and a host of related phenomena
involving the distortion of light as it passes through the diseased cornea.

In addition to Dr. Donzis, plaintiffs called Albert Lyter,
Ph.D., from Raleigh, North Carolina. Dr. Lyter is a former federal agent trained
in ink dating analysis. Dr. Lyter testified that Dr. Niksarli intentionally
artificially aged a note in his chart concerning his purported conversation with
the patient and his wife concerning the risks, benefits, and alternatives to
LASIK surgery.

Anthony Gamboa, Ph.D., also testified as an expert in
vocational economics concerning plaintiff’s loss of income. Dr. Gamboa is from
Miami, Florida.

Dr. Niksarli called Wing Chu, M.D., from New York City, to
discuss his so-called independent examination of the plaintiff. On
cross-examination, Dr. Chu testified that his version of the Hippocratic Oath,
in part, translates to first do no harm to any ophthalmologist.

Dr. Niksarli also called Peter Hersh, M.D., from Teaneck, New
Jersey, as his cornea expert. On cross-examination, Dr. Hersh indicated that he
only testified for defendants’ counsel, who had previously represented him in
his own medical malpractice case.

The plaintiffs were represented by Todd J. Krouner, from
Pleasantville, New York. In 2005, Mr. Krouner obtained the largest verdict for
LASIK malpractice, in the amount of $7.25 million. See Schiffer v. Speaker,
Index No. 101191/03 (Supreme Court New York County 2005).

The defendants were represented by Neil H. Ekblom, of Clausen
Miller, in New York, NY. Prior to this verdict, Mr. Ekblom’s webpage boasted
that he had obtained a string of 19 consecutive defense verdicts.

For further information, please contact Todd J. Krouner at
(914) 769-8700.

 

Study: Glasses After Lasik PDF Print E-mail


SOURCE

They had Lasik
surgery but still need glasses.

A new Consumer Reports Health survey finds
that while 80 percent of people who’ve had Lasik or other laser
vision-correction surgery are “completely” or “very satisfied,” 55 percent of
those who had gone through the procedure said they still had to wear glasses or
contact lenses at least occasionally.

Although many expected this would be the
case, most (61 percent) said they were disappointed about that. The majority of
respondents (56 percent) say they had the surgery-often pitched as an
alternative to glasses-to correct nearsightedness.

The survey was of 793 adults who had laser
vision correction surgery since 2001.

“The typical national price (per eye) for
laser vision surgery is $1,657, yet the survey reveals wide variation in costs
per eye. Seven percent of consumers who reported their costs said they paid less
than $499 per eye; 12 percent paid between $2,500 and $3,999 per eye; and 4
percent shelled out $4,000 or more per eye. Twenty-three percent of respondents
were unsure of what they paid.

“The surgery is not without risk: 53 percent
of those surveyed experienced at least one side effect within the first four
weeks of the surgery and 22 percent of patients experiencing them six months
after surgery, especially dry eyes and visual symptoms like halos, glare, and
starbursts around lights.

“The majority (56 percent) of respondents
had the surgery to correct nearsightedness, while others had it done for
astigmatism (35 percent) and farsightedness (20 percent).

“Satisfaction with one’s surgeon is key-it
strongly predicts overall satisfaction with laser eye surgery, even more so than
where the procedure is performed. Thus, choosing a surgeon carefully is more
important than choosing the pace of surgery. Consumer Reports Health offers
detailed tips for selecting the right surgeon.

Consumer Reports Health has noted in a
previous report that some of the low prices advertised for vision surgery can be
potentially misleading. Among other things, the price quoted may be for only one
eye. And if a free consultation is offered, you have a right to just that.

The U.S. Food and Drug Administration has
taken a hard look at Lasik eye surgery, spurred in part by a lack of reliable
data about how often side effects occur. “Laser vision correction surgery is a
largely unchecked industry and consumers need to know the right questions to ask
to be sure they’re protected and that they’re getting good quality care for
their money,” said John Santa, M.D., director of the Consumer Reports Health
Ratings Center. “Vision correction surgery is increasingly popular but there is
a concerning lack of unbiased, concrete evidence about its safety and efficacy.”

It’s not easy to sort through the evidence
surrounding vision-correction surgery, as much of the current available research
comes from surgeons who do the procedure, and who may be more likely to publish
positive results, said Santa. In addition, various surgeries and lasers offer
advantages in specific circumstances, but Santa notes that the lack of
well-designed comparisons makes it impossible at this time to identify one laser
vision corrective surgery as better than another overall.

Since the vast majority of consumers pay
most or all of the costs of the procedures out of pocket, the new Consumer
Reports Health Patient Power Tool Kit, available to subscribers, will help
consumers get high quality care at the right price. The tool kit will:

“Help determine whether you’re likely to be
satisfied based on your personal odds and expectations.

“Provide detailed information from consumers
who have undergone the surgery.

“Give a safety assessment of laser
vision-correction surgery, based on the latest evidence.

“Guide you through the decision process,
including key questions to ask your surgeon and red flags that should alert you
about getting a second opinion.

“Tell consumers what to expect before,
during, and after the surgery.

“Detail the costs of surgery, insurance
coverage, and payment strategies.

The tool kit is available to subscribers at
www.ConsumerReportsHealth.org.

 

Synthetic Fibers to Reverse Blindness PDF Print E-mail
SOURCE

Eric Bland, Discovery News

June 1, 2009 — Synthetic fibers can now be embedded with three, and possibly more, drugs or proteins. The new fibers could be woven into a variety of materials that have unique and novel properties — such as reversing
blindness.

“The ultimate idea is to implant this material into the eye,” said Bin Dong, a scientist from Drexel University who, along with Gary Wnek and Meghan Smith of Case Western University, detailed their work in the journal Small.

“One protein will eat the scar tissue away, and the other will help induce the differentiation of retinal progenitor cells,” said Dong.

Previously scientists were only able to include one drug or protein inside an electrospun fiber because the two would often interact with each other in ways that would negate or modify their effects.

To get around this limitation, the Drexel and Case Western scientists put the drugs and proteins inside tiny capsules, which stop the molecules from interacting with each other until they break apart.

For their first tests, the scientists incorporated both bovine albumin serum (BAS) and epidermal growth factor (EGF) into the same electrospun fiber. Each molecule was also linked to a particular fluorescent dye that appears under special light. Red for BAS, green for EGF.

A fleece or nylon that glows different colors at different times is the beginning, though. Restoring vision to the blind could be the first use for these drug- and protein-containing fabrics.

Working with Michael Young, an ophthalmologist at the
Schepens Eye Research Institute, the Drexel and Case Western University researchers are trying to create a biodegradable synthetic fabric that could return sight to blind people.

Surgically implanted onto the retina during a 45-minute operation, the protein-equipped fabric would do two things. First, proteins in the fabric would eat away at the scar tissue created by diseases like retinitis pigmentosa and macular degeneration.

Once that’s done, other capsules would break apart and release a growth factor that would encourage cultured retinal progenitor cells on top of the fabric to create new, light-detecting cells. The nanofiber material would then provide a place for these new cells attach to and grow on. Once the cells were established — between 24 and 48 hours — the material would naturally degrade.

“We’ve been able to show that in mice we can restore some kind of meaningful vision,” said Young. “Pigs have compatible cells, and the next step is to restore vision for them as well.”

If the animal trials go well, Young estimates that it will be a minimum of three years before any human trials of the material can be attempted.

“It sounds very exciting that they were able to incorporate multiple proteins,” said Paula Hammond of the Massachusetts Institute of Technology, who
works with electrospun materials.

“This could be especially interesting for tissue regeneration and wound healing applications,” said Hammond.

 

Stem Cells to Make Lasik Obsolete PDF Print E-mail
April 19, 2009 by


SOURCE

The Mice
with Stem Cell Eyes

Researchers at University of
Pittsburgh
School of Medicine have successful restored the vision of mice with
corneal defects using
stem cells treatments.
The
stem cells were injected directly into the cornea of the mice. Upon
completion of the stem cell

treatment
the eyes of
the mice are reported to look no different than the undamaged eyes of other
mice.

Further the musculus subjects of this corneal stem cell experiment displayed no
signs of immune system rejection, even when human
stem cells were used during the test. This suggests that the immune system
may not discriminate against stromal
stem cells in the eye even when they are not harvested from the same
species.

The main argument against
stem cell research has historically been voiced by those who disagree
with the destruction of
human embryos for the sole purpose of stem cell harvesting. However, the
research at University of
Pittsburgh School of Medicine may have found a way to side step the issue.
At least as far as our eyes are concerned. If mice, with one of the most robust immune systems in
existence, do not reject human
stem cells injected into their corneas, then it stands to reason that
humans, who have a much less proactive immune system, would have no problem
accepting injections of rodent stem cells.

While for many of us having rat-eyes might not be the most appealing thought,
the benefits surely outweigh the gross factor. Unlike dangerous corneal
replacement surgery and Lasik (laser surgery), both of which are temporary
solutions which eventually degrade, corneal
stem cell therapy appears to be a permanent solution. Add the reduced
risk of immune system rejection, and a near endless supply of non-morally
ambiguous stem cells and we may be witnessing the end of Lasik.

 

K-State professor awarded $1.48 million to study LASIK complications PDF Print E-mail


SOURCE

 

Contact:
Gary Conrad

gwconrad@k-state.edu

785-532-6662
Kansas
State University

Gary Conrad, a university distinguished professor at Kansas State University’s
Division of Biology, has received a four-year grant renewal of $1.48 million
from
The National Eye Institute of the
National Institutes of Health to study the cornea.

“The NIH renewal will make
Conrad’s grant the longest continuously funded R01 grant in the state of Kansas
at 41 years,” said Jim Guikema, K-State associate vice president for research.

From the beginning, Conrad has been fascinated by the unique structure of the
cornea.

“Among all body tissues, the cornea is unique in being transparent, very highly
innervated, free of blood vessels
and yet composed of three layers of living cells,” he said.

Conrad’s research on
embryonic development of the eye has led to knowledge that could possibly
improve LASIK surgery. He and his
research associates have identified a difference in the connective tissue of
normal corneas compared to those that have been cut during LASIK.

LASIK, which stands for laser-assisted in situ keratomileusis, is a surgery
using a laser to reshape the cornea as an alternative to wearing glasses or contact lens. During the
procedure a thin-hinged flap is cut in the front of the cornea and peeled back
out of the way to allow the laser to reshape the corneal connective tissue
underneath the flap. When the laser is finished the flap is pulled back to its
original position.

It was once believed that the flap
would re-adhere permanently. However, the unique connective tissue
of the cornea and a lack of blood vessels limit its ability to fully heal even
years after the procedure,” Conrad said. “A trauma to the face, such as impact
from an automobile air bag provides enough force to dislodge the flap, reopening
the cornea, infecting it with dirt and debris, and causing instant loss of visual acuity.

After LASIK, differences in the structure of sugar molecules made the cornea
prevent cut nerve ends from regenerating, as well as preventing the flap from
re-adhering. However, the
National Institutes of Health grant renewal will enable the lab group to
test a possible solution that would strengthen the stromal flap and allow it to
permanently bind back to the cornea after LASIK, Conrad said. It uses a
combination of riboflavin and UVA light to permanently cross-link the connective
tissue of the flap to the underlying corneal connective tissue. The treatment is
currently in
clinical trials in the U.S. for another eye dysfunction known as
keratoconus
.

The density of sensory nerve
fibers that normally develop in our cornea is higher than anywhere else
on the surface of our entire body
,” Conrad said. “However, they regenerate
extremely slowly if they are cut, so if we could get those nerves to regenerate,
it would be a major medical advance
.”

Since the grant began in 1971, Conrad’s lab group has discovered many properties
of embryonic and adult corneas. He credits these accomplishments to the research
professors, postdoctoral
research associates, graduate students, research assistants and
undergraduates in his lab who co-author many research publications that have
made continuing grant funding possible.

His closest colleagues include his wife, Abigail Conrad, a K-State molecular,
cellular, and developmental biologist; Yuntao Zhang, a K-State structural
carbohydrate chemist; Peter Lwigale, a 2001 K-State doctoral graduate in biology
and now an
assistant professor at
Rice University; Scott McCall, a K-State senior in biology and
biochemistry and a 2008 Goldwater Scholar from Parker, Colo.; and Conrad’s first
doctoral student Gerald Hart, director of the department of biological chemistry
at the
Johns Hopkins University School of Medicine, Baltimore, Md.

Conrad is known for mentoring and encouraging undergraduates in his lab. As a
result, Conrad has recommended McCall for a summer position in Hart’s lab,
researching structural chemistry.

“Our molecular biology research
is only as good as our K-State freshmen dishwashers and autoclavers, so we try
to train them carefully, listen to their questions, and counsel them as our
closest research colleagues,” Conrad said. “They teach us many things.”

 

UK reporter seeks comments on LASIK PDF Print E-mail


SOURCE

Why did my fabulous laser eyes go lazy again?
By Victoria Lambert
07th March 2009

Quote:
By the next morning I had full and fantastic vision. No hitches, no pain and I
honestly thought I would never look back. On a good day, I could see for miles.

Fast-forward to 2009, and here I am wearing specs again. I can’t even drive
without them.

Am I a scientific freak? Or will this reversal eventually happen to all the
estimated 70,000 Britons who undertake laser eye surgery annually?

Quote:
Have you had a similar experience to Victoria? If so, email health@mailonsunday.co.uk

 

Laser eye surgery – you could be risking blindness PDF Print E-mail


SOURCE

Monday, February 16, 2009, 09:16

Safety lawyers are warning Somerset residents that they could be gambling with
their sight if they choose to undergo laser eye surgery.

The Association of Personal Injury Lawyers (APIL) has issued a
warning stating that because the procedure is unregulated, patients could end up
being treated by doctors without the right skills or experience.

APIL chief executive Denise Kitchener said: “It is imperative to
ask the right questions before undergoing laser eye surgery.

“At the moment it is the patient’s responsibility to investigate
the practitioner’s skills and training, and the only legal demand for doctors is
that they are registered with the General Medical Council.

“The fact the industry is not regulated in any way is shocking,
as someone who is inexperienced and has no specific training in this area can
perform the surgery. This means there is a huge disparity in the quality of
treatment available.”

The Government’s clinical watchdog, the National Institute for Clinical
Excellence, says laser eye surgery should not be offered to patients routinely
on the NHS, and that it is the NHS that often has to pick up the pieces when
private surgery goes wrong.

“Many injuries are the result of patients not receiving
appropriate counselling, or not being able to see a qualified ophthalmologist
before and after the operation,” said Ms Kitchener.

“People may not realise the practice is unregulated – it is
commonplace today to see it widely advertised, and the assumption would be that
it is a safe procedure. While we’re sure there are many skilled practitioners,
the danger comes from the ones who are not competent.”

For further information, visit the APIL website at www.apil.org
.uk.

 

Lawmakers target inferior Lasik eye procedures PDF Print E-mail

Feb. 21, 2009
Las Vegas Review-Journal

By ANNETTE WELLS

 

Quote:
AB196 adds to existing law regulating refractive eye surgery centers by
requiring that ophthalmologists be licensed to perform the procedures through
the Nevada State Health Division.

The bill also requires that facilities that offer refractive surgery ensure that
a licensed ophthalmologist perform those procedures and that the ophthalmologist
is available for preoperative and postoperative care.

The bill also authorizes the state’s health division to issue a cease and desist
order if it learned a refractive surgery facility is operating without a
license.


Link to full text of article

 

NEI lists LASIK as a cause of cataracts PDF Print E-mail

SOURCE

Quote:
The DLS technique will now assist vision scientists in
looking at long-term lens changes due to aging, smoking, diabetes,

LASIK surgery, eye
drops for treating glaucoma, and surgical removal of the vitreous gel within
the eye, a procedure known to cause cataracts within six months to one year.

Full text of the press release:

For Immediate Release
Thursday, January 8, 2009

National Eye Institute
496-5248

Katherine K. Martin
NASA Glenn Research Center
216-433-2406

From Outer Space to the Eye Clinic: New Cataract Early Detection Technique

Patients and Astronauts Benefit from NEI-NASA Collaboration

A compact fiber-optic probe developed for the space program has now proven
valuable for patients in the clinic as the first non-invasive early detection
device for cataracts, the leading cause of vision loss worldwide.

Researchers from the National Eye Institute (NEI), part of the National
Institutes of Health, and the National Aeronautics and Space Administration
(NASA) collaborated to develop a simple, safe eye test for measuring a protein
related to cataract formation. If subtle protein changes can be detected before
a cataract develops, people may be able to reduce their cataract risk by making
simple lifestyle changes, such as decreasing sun exposure, quitting smoking,
stopping certain medications and controlling diabetes.

“By the time the eye’s lens appears cloudy from a cataract, it is too late to
reverse or medically treat this process,” said Manuel B. Datiles III, M.D., NEI
medical officer and lead author of the clinical study. “This technology can
detect the earliest damage to lens proteins, triggering an early warning for
cataract formation and blindness.”

The new device is based on a laser light technique called dynamic light
scattering (DLS). It was initially developed to analyze the growth of protein
crystals in a zero-gravity space environment. NASA’s Rafat R. Ansari, Ph.D.,
senior scientist at the John H. Glenn Research Center and co-author of the
study, brought the technology’s possible clinical applications to the attention
of NEI vision researchers when he learned that his father’s cataracts were
caused by changes in lens proteins.

Several proteins are involved in cataract formation, but one known as alpha-crystallin
serves as the eye’s own anti-cataract molecule. Alpha-crystallin binds to other
proteins when they become damaged, thus preventing them from bunching together
to form a cataract. However, humans are born with a fixed amount of alpha-crystallin,
so if the supply becomes depleted due to radiation exposure, smoking, diabetes
or other causes, a cataract can result.

“We have shown that this non-invasive technology that was developed for the
space program can now be used to look at the early signs of protein damage due
to oxidative stress, a key process involved in many medical conditions,
including age-related cataract and diabetes, as well as neurodegenerative
diseases such as Alzheimer’s and Parkinson’s,” said NASA’s Dr. Ansari. “By
understanding the role of protein changes in cataract formation, we can use the
lens not just to look at eye disease, but also as a window into the whole body.”

The recent NEI-NASA clinical trial, reported in the December 2008 Archives of
Ophthalmology, looked at 380 eyes of people aged 7 to 86 who had lenses ranging
from clear to severe cloudiness from cataract. Researchers used the DLS device
to shine a low-power laser light through the lenses. They had previously
determined alpha-crystallin’s light-scattering ability, which was then used to
detect and measure the amount of alpha-crystallin in the lenses.

They found that as cloudiness increased, alpha-crystallin in the lenses
decreased. Alpha-crystallin amounts also decreased as the participants’ ages
increased, even when the lenses were still transparent. These age-related,
pre-cataract changes would remain undetected by currently available imaging
tools.

“This research is a prime example of two government agencies sharing scientific
information for the benefit of the American people,” said NEI director Paul A.
Sieving, M.D., Ph.D. “At an individual level, this device could be used to study
the effectiveness of anti-cataract therapies or the tendency of certain
medications to cause cataract formation.”

The DLS technique will now assist vision scientists in looking at long-term lens
changes due to aging, smoking, diabetes, LASIK surgery, eye drops for treating
glaucoma, and surgical removal of the vitreous gel within the eye, a procedure
known to cause cataracts within six months to one year. It may also help in the
early diagnosis of Alzheimer’s disease, in which an abnormal protein may be
found in the lens. In addition, NASA researchers will continue to use the device
to look at the impact of long-term space travel on the visual system.

“During a three year mission to Mars, astronauts will experience increased
exposure to space radiation that can cause cataracts and other problems,” Dr.
Ansari explained. “In the absence of proper countermeasures, this may pose a
risk for NASA. This technology could help us understand the mechanism for
cataract formation so we can work to develop effective countermeasures to
mitigate the risk and prevent it in astronauts.”

The NASA John H. Glenn Research Center is one of NASA’s 10 field centers,
empowered with the resources for developing cutting-edge technologies and
advancing scientific research that addresses NASA’s mission to pioneer the
future in space exploration, scientific discovery and aeronautics research.
Working in partnership with government, industry and academia, the Center serves
to maintain the U.S. economy’s global leadership while benefiting the lives of
people around the world. For more information about NASA Glenn and its programs,
visit www.grc.nasa.gov.

The National Eye Institute (NEI), a component of the National Institutes of
Health, is the federal government’s lead agency for vision research that leads
to sight-saving treatments and plays a key role in reducing visual impairment
and blindness. For more information, visit the NEI Web site at
www.nei.nih.gov.

The National Institutes of Health (NIH) — The Nation’s Medical Research Agency —
includes 27 Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. It is the primary federal agency for conducting and
supporting basic, clinical and translational medical research, and it
investigates the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
www.nih.gov.

 

Nevada Lasik Company Investigated by State PDF Print E-mail
Updated: Oct 29, 2008 09:10 PM EDT

There is an update on an investigation of a local Lasik clinic. State authorities say they’re nearing the end of their review of the Valley Eye Center. Colleen McCarty (Las Vegas Now/Eyewitness News) first broke the story of alleged malpractice at the clinic.

The State Attorney General’s Office plans to complete its investigation of the Valley Eye Center within the next few weeks. Investigators have been exploring allegations that the administrator of the clinic practiced medicine without a license, a claim he adamantly denies.

Suit has been filed against the clinic alleging malpractice and to administrator Vikas Jain, fraudulent concealment. Jain, they claim, provided their pre and post operative care — procedures that, according
to the lawsuits, only a licensed doctor may perform.

Jain lost his medical license in 2005 for harming more than 20 patients in the state of Ohio.



CLICK HERE
for the full story

 

Lasik Surgery Results in Worse Vision and Never-Ending Pain PDF Print E-mail

SOURCE

According to Dr. Kerry Soloman, who did a study of Lasik’s safety for the American Society of Cataract and Refractive Surgery, a full five percent have poor results. These can be worse vision — even blindness — constant eye pain, blurred vision, dry eyes, and a variety of other distressing visual aberrations. Interestingly, people who end up with corrected vision but permanent eye pain are considered successes by the surgeons who do the procedure.

About 48% — nearly half –- suffer from dry eyes at least temporarily after the surgery. Because the surgery severs the cornea nerves that stimulate tear production, this has been an obvious and predictable problem.

About 700,000 people have Lasik surgery every year. With about 5% of them having bad results, that translates to about 35,000 people who ended up worse, with pain or with visual disturbances, such as double-vision and halos around lights.

The FDA is now investigating the risks associated with Lasik surgery, but one must wonder where the agency has been for the last 19 years, when the surgical technique was first patented. The first Lasik machine was approved by the FDA about ten years ago.

Lasik is Just Another Industry

The Lasik industry is like any other. Its primary motivation is profits, and this one’s are enormous. The following quote is by Dr. Marguerite B. McDonald, the former Chief Medical Editor of EyeWorld, an international publication for ophthalmologists:

“We are only starting to ride the enormous growth curve of Lasik in this country. There will be more than enough surgeries for everyone to benefit if we keep our heads by sharing information openly and honestly and by resisting the temptation to criticize the work of our colleagues when we are offering a second opinion to a patient with a suboptimal result.”

She clearly implies that the patients’ welfare is of secondary importance to the doctors’ profits! Dr. McDonald is a major player in the field of Lasik surgery. Think of what this implies about the safety of the process and the dishonesty inherent in many doctors doing it.

Of course, this shouldn’t be surprising. Consider all the ophthalmologists who now specialize in only Lasik surgery. Instead of putting their efforts into procedures that might help people at risk of losing their sight, they have opted to do nothing but provide a risky and unnecessary procedure.

Long Term Results May Include Suicide

Long term results are proving to be even worse. Lawsuits are popping up now as a result of problems developing years later.

Colin Dorrian was a 28-year-old patent lawyer. In the summer of 2007, he killed himself, leaving a note that blamed constant pain from Lasik surgery. He wrote, “I just cannot accept the fact that I’m supposed to live like this.”

Within the industry, there is complete denial of any cause-and-effect between Lasik and suicide. Of course, there have been no studies to see if there’s a connection.

One optometrist, Chistine Sindt, who is also a University of Iowa associate professor of clinical ophthalmology, says that she has seen depression in people with vision problems caused by Lasik. “It’s not just that they lose vision. They paid somebody… who took their vision away.”

Naturally, the Lasik industry explains this sort of thing by saying that the people who become depressed suffered from psychological problems before the surgery. One would think, though, that any doctor whose first interest is in the patient’s welfare would want to err on the side of caution. Instead, though, there has been denial.

Permanent Pathological Changes in All Lasik Patients

In a study published by Cornea in January 2005, it was reported that, of 25 post-mortem Lasik patients, every single one of them had suffered pathological corneal changes that were permanent. There were no exceptions. These patients had died between 3 months and 7 years after their surgeries, and the only determinant for selecting a case for examination was that the person’s visual status prior to the surgery was known.

Corneas Do Not Heal Completely After Lasik

In the September-October issue of the Journal of Refractive Surgery, a report of a study on the healing of Lasik patients reported that most do not achieve anywhere near the quality of structure that’s achieved from most corneal wounds. The relative strength of the Lasik-induced wound’s tissues average only 2.4% of normal tissue. Wounds gotten in an accidental manner typically develop scars with 28.1% the strength of normal tissue.

In the Journal of Refractive Surgery’s April 2007 issue, the authors stated, “The Lasik flap once cut may contribute little to the mechanical stability of the cornea and probably never completely adheres to the underlying stromal bed.”

Lasik patients are left with permanently weakened corneas. This means that they are forever at risk of permanent eye damage from relatively minor injuries. Those who are most at risk of suffering permanent damage as a result of Lasik surgery, people who are involved in highly physical sports or jobs, are the ones who are often targeted by the industry. Clearly, the best interests of the patients are not the doctors’ primary concern.

Potential Damage From Lasik Surgery

Lasik surgery has not been in existence for long, only about ten years. Its long term effects are not yet known, but there are many reasons to be concerned.

There are some indications that the procedure may induce cataracts. Many people, including relatively young ones, have claimed that cataracts were induced by Lasik surgery. There have not, of course, been any studies to see if there’s a connection.

Lasik procedures literally evaporate part of the cornea to produce a smooth surface. This is known to create free radicals and apoptosis (cell death and dismemberment) in the stromal, underlying, structure of the cornea. Free radicals are known to cause tumor growth. It may be decades before we see results of this damage –- or it may be entirely harmless. Only time will tell.

In November 2007, EyeNet Magazine, a publication of the American Academy of Ophthalmology, reported ectasia, bulging of the cornea, years after Lasik surgery. Joe McFarland, MD, JD stated, “We are also just now learning of some of the long-term complications of refractive surgery, which are being reflected in new allegations and lawsuits. For example, some patients are developing post-refractive ectasia years after the procedure; this condition not only compromises vision, but also may need to be treated with a corneal transplant.”

At least one case of neuropathy to both optic nerves of a patient was noted by the journal, Opthalmology in April 2008. It is surmised that the cause was elevation of intraocular (within the eye) pressure induced by a suction ring device routinely used during Lasik procedures. It resulted in several severe vision defects.

A consistent result of Lasik surgery is that people over age 40 who had been able to see things close to them without glasses suddenly require glasses for reading. They have only exchanged distance-vision glasses for reading glasses.

Lasik surgery changes the cornea’s shape and thickness. As a result, intraocular pressure readings, which are critical for diagnosing glaucoma, become inaccurate. This may result in lost vision from glaucoma that goes undiagnosed.

Do You Want to Take the Risk of Lasik Surgery?

Laser sounds so much safer than a knife, but keep in mind that it cuts as sharply as any weapon. One of the primary processes of Lasik surgery is melting part of the cornea to make it smooth. The result is that even the best possible outcome results in poor healing, leaving all, or nearly all, patients at significantly greater risk of permanent eye damage from injury. Aside from the immediate risks of seriously impaired vision and permanent eye pain, the long term risks are only now coming to light.

Is Lasik surgery worth the risk? I’ll leave that up to you.

References:

LasikDisaster, (http://lasikdisaster.com/studies.htm)

Associated Press, ((http://hosted.ap.org/dynamic/stories/L/…)

Washington Post, ((http://www.washingtonpost.com/wp-dyn/co…)

Columbia Tribune, ((http://www.columbiatribune.com/2008/Feb…)

About the author
* Heidi Stevenson, BSc, DIHom, FBIH
* Fellow, British Institute of Homeopathy
* Gaia Therapy (http://www.gaia-therapy.com)
*
* The author is a homeopath who became concerned with medically-induced harm as a result of her own experiences and those of family members. She says that allopathic medicine is the arena that best describes the motto, “Buyer beware.”
*
* Iatrogenic disease is illness, disability, and death caused by medical practice. It is common, resulting in huge costs to society and individuals. It’s possible – even common – to suffer an iatrogenic illness without realizing its source.
*
* Heidi Stevenson provides information about medically-induced disease and disability, along with incisive well-researched articles on major issues in the modern world, so members of the public can protect themselves.

 

Awareness of Drug-Induced Eye Toxicity Crucial for Patients, Physicians, PDF Print E-mail
Says Public Citizen on WorstPills.org

Article in ‘Drug Safety’ Identifies 62 Drugs That Can
Cause Eye Disease

April 1, 2008

WASHINGTON, D.C. – Physicians and patients should be aware of
the slew of drugs that can cause eye disease and be diligent in identifying
potential adverse effects, Public Citizen writes in a new March posting on its WorstPills.org
Web site.

A recent paper published in Drug Safety identifies 62
drugs that can cause adverse reactions to the eye. Public Citizen summarizes the
paper’s findings, highlights these reactions and describes how they relate to
structures in the eye and certain eye conditions.

The eye is composed of a plethora of different types of cells,
and drugs can affect each type. The 62 drugs can cause a host of different eye
diseases, including cataracts, glaucoma, eye surgery complications, eyelid and
conjunctival diseases, optic nerve diseases and retinal abnormalities. Loss of
color vision, blurred and impaired vision, decreased night vision, skin lesions
and blindness are just some of the symptoms people who develop these diseases
can experience.

While people are aware of the undesirable effects drugs can
have on organs in the body, they often don’t consider the potential risks to
their eyes.

“The eye is a crucial organ, and it is important that
physicians and patients understand the risks associated with certain drugs,”
said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

WorstPills.org includes the full list
of implicated drugs cited in the Drug Safety article. Some examples
include: chloroquine and hydroxycholoroquine, used to treat rheumatoid
arthritis, lupus, amoebae and malaria; the antibiotic linezolid; ethambutol,
used to treat tuberculosis; corticosteroids; alpha-1 blockers, particularly
tamsulosin; botulinum toxin (Botox); morphine administered intravenously or by
mouth; and drugs in the anticholinergic and adrenergic categories.

Just as patients check for drug-induced diseases in other
parts of the body when starting new medications, they also should consider newly
developed eye symptoms, Wolfe said. Early detection and various eye examinations
are crucial, since some conditions, such as retinal damage, are reversible only
during the earliest stages of the disease.

Worst Pills, Best Pills is a
monthly newsletter available in print and electronic formats through Public
Citizen’s subscription Web site,
www.WorstPills.org. The site has other searchable information about the
uses, risks and adverse effects associated with prescription medications,
including all the information contained in Public Citizen’s best-selling book,
“Worst Pills, Best Pills.”

WorstPills.org is an unbiased analysis
of information from a variety of sources, including well-regarded medical
journals and unpublished data obtained from the Food and Drug Administration,
that allows Public Citizen to sound the alarm about potentially dangerous drugs
long before they are banned by the federal government. For example, Public
Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol and
Propulsid years before they were pulled from the market.

 

LASIK failure toll can be high PDF Print E-mail

SOURCE

FDA to study effects of
complications from eye surgery; some blame them for depression, suicide

By Sabine Vollmer

McClatchy-Tribune newspapers

February 25, 2008

RALEIGH, N.C.

Patients who undergo
vision-correcting laser eye surgery sign a release form with an extensive list
of risks, but some researchers and former patients say a potential complication
is not mentioned: depression that can lead to suicide.

In response to patient
complaints, the Food and Drug Administration plans to convene a large, national
study to examine the relationship of LASIK complications and quality of life,
including psychological problems such as depression.

Malvina Eydelman, an
ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote
in an e-mail that the scant clinical data available “failed to suggest
significant problems following LASIK surgery.”

But she said the FDA wants a
broad and systematic review. She wrote, “We also noted that quality of life
issues related to LASIK had not been evaluated consistently, and there were few
reports of well-designed studies.”

Frustration and sorrow can
follow any unsuccessful surgery, but when the procedure leaves a patient with
unremitting eye pain or permanently impaired vision, the emotional toll can be
severe.

One who could not endure it
was Colin Dorrian, 28, a patent lawyer and aspiring medical student from
suburban Philadelphia. He committed suicide last summer, six years after LASIK
surgery left him with lasting visual distortions. The surgery was done at a
LASIK center in Canada that has since closed.

“If I cannot get my eyes
fixed, I’m going to kill myself,” he wrote in a note police found.

In the note, Dorrian wrote
that there had been other instances when he felt down. “I have other problems
like most people do. But this is something else,” he wrote. “As soon as my eyes
went bad, I fell into a deeper depression than I had ever experienced, and I
never really came out of it.”

Laser eye surgeons who treat
patients with complications say they do come across cases of depression, but
they don’t think LASIK complications are the root cause. They say patients who
exhibit depression after the procedure were likely depressed or psychologically
troubled beforehand.

“There’s no cause and
effect,” said Dr. Steven Schallhorn, the former head of the Navy Refractive Surgery Center
in San Diego and an expert on permanent visual distortions from LASIK.

Christine Sindt, an
optometrist and associate professor of clinical ophthalmology at the University
of Iowa in Iowa City, has encountered the psychological effects that patients
experience when they have trouble seeing.

“Depression is a problem for
any patient with a chronic vision problem,” she said. But in the case of post-LASIK
patients, she said, the depression is compounded by remorse.

“It’s not just that they
lose vision,” she said. “They paid somebody [who] took their vision away.”

Dr. Alan Carlson, a laser
eye surgeon at the Duke Eye Center
in Durham, built his career on correcting the vision of patients at high risk of
complications. He said people at risk of depression or anxiety are generally not
good candidates for LASIK. He compared them to patients who become depressed
after undergoing cosmetic surgery.

“Their motivation and
expectations may reflect something they’re missing in their life that they’re
not telling you about,” he said.

In 2006, the FDA began to
look into LASIK complications and quality-of-life issues and determined more
research was needed.

A task force that includes
representatives of the National Eye Institute and the National Institutes of
Health has since formed to design a large study that would be conducted by laser
eye surgeons across the country.

The FDA is also planning a
public meeting to discuss experiences with LASIK devices since their
introduction to the U.S. market.

Mostly
safe, successful

Since the mid-1990s,
numerous studies have shown that the surgery known as laser-assisted in-situ
keratomileusis, or LASIK, is safe and successful in most cases and has become
more so with new technology. Most of the 1.3 million Americans who undergo the
surgery every year are happy with the results. The American Society of Cataract
and Refractive Surgery, which represents about 9,000 ophthalmologists
specializing in laser eye surgery, suggests that only 2 percent to 3 percent of
LASIK patients experience complications.

 

Some link depression, failed lasik PDF Print E-mail
Patients with impaired sight turn suicidal; surgeons reject any connection


Sabine Vollmer
, Staff Writer

Patients who undergo vision-correcting laser eye surgery sign a release form with an extensive list of risks, but some researchers and former patients say a potential complication is not mentioned: depression that can lead to suicide.

In response to patient complaints, the Food and Drug Administration plans to convene a large, national study to examine the relationship of lasik complications and quality of life, including psychological problems such as depression.

Malvina Eydelman, an ophthalmologist with the FDA’s Center for Devices and Radiological Health, wrote in an e-mail message that the scant clinical data available “failed to suggest significant problems following lasik surgery,” but she said the FDA wants a broad and systematic review. She wrote, “We also noted that quality of life issues related to lasik had not been evaluated consistently, and there were few reports of well-designed studies.”

Frustration and even sorrow can follow any unsuccessful surgery, but when the procedure leaves a patient with unremitting eye pain or permanently impaired vision, the emotional toll can be particularly severe.

One who could not endure it was Colin Dorrian, 28, a patent lawyer and aspiring medical student from suburban Philadelphia. He committed suicide last summer, 6 1/2 years after lasik surgery left him with lasting visual distortions. The surgery was done at a lasik center in Canada that has since closed.

“If I cannot get my eyes fixed, I’m going to kill myself,” he wrote in a note police found on his body. “I just cannot accept the fact that I’m supposed to live like this.”

In the note, Dorrian wrote that there had been other instances when he felt down. “I have other problems like most people do. But this is something else,” he wrote. “As soon as my eyes went bad, I fell into a deeper depression than I had ever experienced, and I never really came out of it.”

Laser eye surgeons who treat patients with complications say they do come across cases of depression, but they don’t think lasik complications are the root cause. They say patients who exhibit depression after the procedure were likely depressed or psychologically troubled beforehand.

“There’s no cause and effect,” said Dr. Steven C. Schallhorn, the former head of the Navy Refractive Surgery Center in San Diego and an expert on permanent visual distortions from lasik.

In September, The News & Observer reported on complications from lasik, a lightly regulated surgical procedure widely promoted as a quick and painless way to eliminate the need for eyeglasses. But patients across the country and in laser eye surgery hot spots such as the Triangle, where 11 laser eye surgery centers operate, say the physical after-effects can cause or aggravate psychological problems.

Christine Sindt, an optometrist and associate professor of clinical ophthalmology at the University of Iowa in Iowa City, Iowa, has encountered the psychological effects that patients experience when they have trouble seeing.

“Depression is a problem for any patient with a chronic vision problem,” she said. But in the case of post-lasik patients, she said, the depression is compounded by remorse.

“It’s not just that they lose vision,” she said. “They paid somebody [who] took their vision away.”

Sindt specializes in treating ectasia, a bulging of the eye that is considered the most severe and rarest lasik complication. She sees a few dozen patients with ectasia; all of them show signs of depression, she said.

Lasik usually safe

Since the mid-1990s, numerous studies have shown that the surgery known as laser-assisted in-situ keratomileusis, or lasik, is safe and successful in most cases and has become more so with the introduction of new technology. Most of the 1.3 million Americans who undergo the surgery every year are happy with the results. The American Society of Cataract and Refractive Surgery, which represents about 9,000 ophthalmologists specializing in laser eye surgery, suggests that 2 percent to 3 percent of lasik patients experience complications.

But surgeons agree that lasik is unlike a face-lift or even most necessary surgery because it affects a process — seeing — that is essentially a mental function. The eyes focus light, but what a person actually sees depends on how the brain decodes an image. Neurological differences in decoding explain why dyslexics reverse letters and why alcohol consumption can produce double vision.

Although laser eye surgery has been around for years, little research has been done to explore how the ability to see affects how people feel and act. In 2006, the FDA began to look into lasik complications and quality-of-life issues and determined more research was needed. A task force that includes representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study that would be conducted by laser eye surgeons across the country.

Vision-mind connection

The FDA is also planning an open public meeting this spring to discuss experiences with lasik devices since their introduction to the U.S. market.

A few researchers have already looked at whether changes in vision can affect the mind. Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery.

Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had lasik as among cornea donors who had not. But the data were incomplete and the numbers could be significantly skewed, said Dr. Henry Edelhauser, the professor of ophthalmology who oversaw the Emory study. One of the participating eye banks failed to provide vital statistical data.

Research that Schallhorn did at the Navy Refractive Surgery Center suggests a relationship between satisfaction after lasik and certain personality traits among patients. Schallhorn declined to provide details. Like the results of the Emory suicide study, his research has not been published in peer-reviewed journals.

But some patients are unequivocal: Lasik complications drove them to contemplate suicide.

In Cleveland, Tenn., Kim Hybarger, 44, a nurse, developed debilitating visual distortions after lasik surgery Dec. 21, 2006. She tried to walk into traffic, cut her throat and starve herself.

“I was filled with anger,” she said. “I felt so hopeless and helpless. I just wanted to die. The way I saw was so frightening.”

Hybarger’s mental state didn’t improve until Ed Boshnick, a Miami optometrist, offered to fit her with special contact lenses.

Sales of the special lenses have increased with the rising number of Americans who had lasik since 2000. The lenses can restore the cornea’s shape and correct visual distortions.

New lenses help

Boshnick is one of a handful of specialists who have had considerable success fitting the lenses. Hybarger is one of about 250 patients with complications from lasik who regularly see Boshnick. About half of them suffer symptoms of depression, Boshnick said.

The new lenses can clear up more than vision.

Hybarger left Miami remembering the moment she first looked through them.

“It was indescribable,” Hybarger said. “It was like the first time I smiled in a year.”

The complete article can be found
HERE
.

 

2 New Lenses For Post Refractive Surgery PDF Print E-mail
Optometrists and ophthalmologists that work with post-op LASIK problems have 2 brand new lenses at their disposal.

First, J&J
Acuvue OASYS now comes in a brand new 8.8 mm base curve, which fits flat on normal eyes but fits well on surgically flattened RK or LASIK eyes.

Second,
SynergeyesPS is the first FDA-cleared hybrid contact lens especially designed for patients with oblate corneas resulting from
refractive surgery.

 

Singapore halts Lasik surgery after inflammation cases PDF Print E-mail
SCIENCE NEWS

March 14, 2007

A key Singapore eye hospital has suspended Lasik eye-sight correction surgery after a surge in the number of patients suffering from inflammation.

The Singapore National Eye Center (SNEC) halted all Lasik surgeries last week after 17 patients suffered from the Diffuse Lamellar Keratitis inflammation following treatments, according to Ravi Chandran, the center’s spokesperson said on Wednesday.

“SNEC has recently seen an unusual increase in inflammatory reaction in patients after lasik treatment,” Chandran said, adding that the cause of the inflammations is still unknown.

Singapore is trying to establish itself as a medical center for foreigners. Some 200,000 overseas patients seek medical care in Singapore each year, more than half of them from neighboring Indonesia.

Patients who suffer from the Diffuse Lamellar Keratitis inflammation do not experience any pain or discomfort, but may have blurry vision for one to two weeks, Chandran said.

The suspension, which is the first-ever in the Southeast Asian city-state, is expected to at least last until the end of the month, according to Chandran.

 

Beta-Blocker Eye Drops Can Cause Serious Adverse Reactions PDF Print E-mail

Public Citizen Reveals on WorstPills.org Web Site

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. – Beta-blocker eye drops, used for treatment of blindness-causing glaucoma, may cause significant adverse effects such as death, heart attack, serious drops in blood pressure, fainting spells and other complications, Public Citizen writes in a new November posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the September 2 issue of The Lancet.

To read the entire press release,
click here.

 

Consumers Often Overdose on Prescription Eye Drops PDF Print E-mail

Public Citizen Reveals on WorstPills.org Web Site

Sept. 1, 2006

WASHINGTON, D.C. – Though many eye drop prescription labels instruct patients to use one or two drops, consumers should only use one drop because there is a lesser risk of overdosing, Public Citizen writes in a new September posting on its WorstPills.org Web site. The consumer advocacy organization cited information published in the June 19 issue of The Medical Letter on Drugs and Therapeutics.

The volume of liquid contained in one eye drop varies with the thickness of the solution, the design of the dropper and the way in which the patient uses the dropper to dispense drops. By administering a second drop, consumers could lower the effectiveness of the first drop by flushing it out or increase the risk of having an adverse reaction by allowing the medication in the drops to enter the blood stream.

A human eye can hold up to 10 microliters of liquid at a time, whereas a single droplet from an eye dropper can range from 25 to 50 microliters. The excess medicine has only two places to go – streaming down the patient’s face in harmless, but expensive, tear-like rivulets or through a small duct in the corner of the eye and into the nose, where it is absorbed into the blood and distributed to the rest of the body.

The full story can be read
HERE

For information on opthalmic conditions such as eye infection, eye inflammation, increased eye pressure, eyelid infection, and dry eyes, please visit Public Citizen’s
Worstpills.org website.

“Worst Pills, Best Pills” Readers Also Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

 

Fusarium Keratitis — Multiple States, 2006 PDF Print E-mail

Fusarium Keratitis — Multiple States, 2006

On March 8, 2006, CDC received a report from an ophthalmologist in New Jersey regarding three patients with contact lens–associated Fusarium keratitis during the preceding 3 months. Initial contact with several corneal disease specialty centers in the United States revealed that other centers also have seen recent increases in Fusarium keratitis. This report summarizes the public health response to date in the United States and provides important prevention messages for contact lens users.

Microbial keratitis is a severe infection of the cornea. Risk factors for infection include trauma (generally with plant material), chronic ocular surface diseases, immunodeficiencies, and rarely, contact lens use (1–3). An estimated 30 million persons in the United States wear soft contact lenses; the annual incidence of microbial keratitis is estimated to be 4–21 per 10,000 soft contact lens users, depending on whether users wear lenses overnight. Fungal keratitis is a condition more prevalent in warm climates; in the southernmost United States, up to 35% of microbial keratitis cases are fungal keratitis, compared with 1% in New York. The proportion of fungal keratitis attributable to Fusarium spp. also varies by region, from 25% to 62%. First-line treatment includes topical and oral antifungal medications; patients who do not respond to medical treatment usually require surgical intervention, including corneal transplantation. Fusarium keratitis is not transmitted from person to person. As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in multiple states. On April 10, this report was posted as an MMWR Dispatch on the MMWR website.

Read more at their website…(http://www.cdc.gov/mmwr).

 

Bausch & Lomb PDF Print E-mail
Bausch & Lomb recalls second contact lens solution

March 2007 – Bausch & Lomb, which has been struggling to recover from a sweeping recall of its ReNu with MoistureLoc contact lens solution, said on Tuesday it had initiated a recall of certain lots of its ReNu MultiPlus contact lens solution.

The company advises consumers to discard any lens care solution that appears to be discolored. The recalled lots all carry the expiration date “2008 – 03” on the bottle.


Read More

Bausch & Lomb Still Unsure Of Mystery Fungus

The company halted U.S. shipments of its ReNu with MoistureLoc contact lens solution Monday night while the Centers for Disease Control and Prevention investigates 109 reports of infection caused by a fungus called Fusarium in patients in 17 states.

The agency has made no direct link between ReNu and the infections, traced back to June 2005, but a high incidence of the affected people had used the solution.

Bausch & Lomb, which also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, stopped short of pulling the brand, made at its factory in Greenville, S.C., but merchants led by Wal-Mart Stores Inc. began removing it from store shelves Tuesday.

Fusarium is commonly found in plant material and soil in tropical and subtropical regions. Without eye-drop treatment, which can last two to three months, the infection can scar the cornea and blind its victims.

Symptoms can include blurry vision, pain or redness, increased sensitivity to light and excessive discharge from the eye. It is not transmitted from person to person.

In February, Bausch & Lomb stopped shipments of ReNu in Singapore and Hong Kong after a similar spike in fungal infections was reported in contact-lens wearers there. It is partnering with health authorities and researchers to investigate the extent and cause of the outbreak, which also surfaced in Malaysia.

More than 30 million Americans wear contact lenses, and the ReNu brand generated $45 million in U.S. sales last year.

You can read more at the following link:


http://www.cbsnews.com/stories/2006/04/12/health/main1493941.shtml?source=RSS&attr=Health_1493941ource=RSS&attr=Health_1493941

This posting was found on a Yahoo Message board 05/03/06 for Bausch & Lomb:



SOURCE

10:43 ET Bausch & Lomb: CDC updates investigation; more than MoistureLoc appears to be at risk – Baird (BOL) 44.20 -4.55: -Update- Baird says the CDC has updated information on 58 fungal keratitis cases (56 contact lens wearers). Of the 56, 57% used ReNu MoistureLoc, 27% Multiplus, and the rest an unknown ReNu product. Firm notes that the association with MoistureLoc and now MultiPlus is far greater than any other competing solutions (to date, firm has yet to confirm that any fungal infections were associated with the exclusive use of a non-BOL solution), and therefore remain concerned that the entire ReNu franchise — not just MoistureLoc — could be at risk. As a reminder, firm has already removed what they believe are the vast majority of ReNu (including MoistureLoc and MultiPlus) sales from their 2006-07 ests, and therefore are making no changes at present to their model.

 

Potential intraocular side effects of ocular steroids PDF Print E-mail

Quote: The potential intraocular side effects of ocular steroids are well known and include a rise in IOP and the formation of cataracts.

EyeWorld

February 2006


SOURCE

 

Long-term LASIK Concerns Expressed PDF Print E-mail

Critical Preop Calculation




Full Article

Sunday, December 17, 2006

Millions of Americans have undergone refractive surgery (RK, PRK, LASIK, LASEK, INTACS, etc.) to reduce or eliminate their need for glasses and contact lenses.

Millions of other Americans receive cataract surgery every year for removal of a cloudy lens. An artificial intraocular lens (IOL) is implanted to substitute for the natural lens.

Now, these two groups of patients are beginning to collide and it’s not very pretty!

Prior to cataract surgery precise measurements and calculations must be performed to determine the appropriate IOL lens power. Measurements include items like the current refractive error and the central corneal curvature. Data is entered into a sophisticated formula using customized computer software. These formulas assume the eye is healthy and has never had previous surgery.

Now, a backstage peek: IOLs are stored in cabinets and organized by different lens powers (+ or – diopters in nearly every power imaginable) just like a shoe store. Miscalculate the IOL power and the patient cannot see clearly afterwards – even if the surgery itself was flawless.

 

Factors consumers should weigh when eyeing surgery PDF Print E-mail


SOURCE

By Washington PostDec 26, 2006 – 06:42:16 am PST

While results have improved for laser eye surgery patients, experts warn that the decision to have surgery should never be made without careful consideration of the potential risks. Lasik and similar procedures are not approved for patients younger than 18, because their vision has not stabilized.Here are some factors consumers should consider: — Some people complain that although they see 20/20 on the eye chart after surgery, their vision is not as crisp as it was with contacts or glasses. People with large pupils and those who are very nearsighted may develop glare or halos, especially at night. Others may have trouble discerning contrast.

— Serious complications are rare — ranging from about 1 to 2 percent of patients, depending on surgeon experience — but they do occur. Some are permanent.

— If you participate in contact sports, Lasik may not be advisable because a blow to the face could dislodge the corneal flap. PRK, a more painful procedure that involves several days of healing time, may be preferable because there is no flap.

 

 

Technology widens eye surgery pool, but skeptics remain PDF Print E-mail

Seeing the big picture

Sun, Dec. 24, 2006

“But not everyone is enamored of the new technology. David Hartzok, an optometrist in Chambersburg, Pa., specializes in treating people with complications from laser surgery. He also directs the Vision Surgery Rehab Network, an advocacy group for patients with post-operative problems.“The people I see coming in today are the products of the new technology, and they’re having the same problems,” such as dry eye, glare, starbursts and blurred vision, Hartzok said. “I do think in general surgeons are more circumspect about the kinds of patients they do and lasers are better.” But that, he said, is no guarantee of a good result.”


Full article

 

Warning from the BBB and FTC PDF Print E-mail
Lasik eye surgery is one of the newest procedures to correct vision problems. But, before you sign up for the surgery, the Better Business Bureau, along with the Federal Trade Commission, suggests you know the facts.

Many people rely on glasses and contacts to correct their vision, but some find these methods inconvenient, uncomfortable or unattractive.


Read More

 

More News & Inside Stories from the Laser Eye Surgery Industry: PDF Print E-mail
LASIK, PRK, LASEK, and ICLs


Read More

 

Study: Some See Stars After LASIK PDF Print E-mail
LASIK surgery might not be the miracle sight cure some patients expect, according to a new study.

Nearly one-quarter to one-third of patients who underwent LASIK surgery reported problems seeing at night, a new study reported.


Read More

 

The National Institute for Health and Clinical Excellence (NICE) has issued guidance on PDF Print E-mail

Photorefractive (laser) eye surgery:

for the treatment of refractive errors (short and long-sightedness) to determine whether it is safe enough and works
well enough for use. The guidance does not recommend that laser eye surgery should be offered to patients routinely on the NHS, as for most people eye problems can easily be corrected by wearing spectacles or contact lenses.

In summary the guidance states that:

– Current evidence suggests that laser eye surgery is safe enough and works well enough for use in appropriately selected patients.

– Clinicians wishing to undertake laser eye surgery should ensure that patients understand the benefits and potential risks of the procedure. Risks include failure to achieve the expected improvement
in unaided vision, development of new visual disturbances, corneal infection, and flap complications. These risks should be weighed against the risks and any possible inconvenience of wearing spectacles
or contact lenses.

– Clinicians should audit and review clinical outcomes of all patients who have laser eye surgery. Further research will be useful and clinicians are encouraged to collect longer-term follow-up data.

– Clinicians should have adequate training before performing these procedures. The Royal College of Ophthalmologists has produced standards for laser refractive surgery.

Read more at their website:
http://www.nice.org.uk/pdf/2006_012_NICE_issues_guidance_on_laser_eye_surgery.pdf

 

Sensitivity of the NEI Refractive Error Quality of Life instrument to RS outcomes PDF Print E-mail
J Cataract Refract Surg. 2005 Dec;31(12):2313-8.

Nichols JJ, Twa MD, Mitchell GL.

From the full text (you won’t see this in the abstract):

Quote:

One might also predict these 2 groups to report a significant difference in glare. However, the design of the clinical trial for these LASIK patients limited enrollment to those who were unlikely to experience this problem (ie, low to moderate myopia and pupil sizes less than 7.5 mm).”


There is something terribly wrong with this picture. They exclude high myopes and patients with large pupils in their “quality of life” survey in order to make LASIK look good.
Some in the industry keep saying pupil size doesn’t matter and others say there’s still debate on whether or not pupil size matters.
But if pupil size didn’t matter, why not include patients with large pupils in these surveys?

It’s all just a big cover-up. They know good and damn well pupil size matters.

 

Low light problems such as glare and halo occur in some 3-5% of patients after PRK or LASIK PDF Print E-mail
The 3 commonest reasons for this are:



Read More

 

Known Risk Factors for Ectasia PDF Print E-mail
Cataract & Refractive Surgery Today

October 2005



http://www.crstoday.com/PDF%20Articles/1005/CRST1005_F3_Trattler.html

 

“Ectasia is one of the most feared postoperative complications of LASIK,” PDF Print E-mail
said Dr. Behrens, cornea surgeon and researcher at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.

While its incidence appears to be low, it is a devastating occurrence for patients with healthy eyes who are undergoing an elective surgical procedure,” Dr. Behrens said at the meeting sponsored by the Johns Hopkins University School of Medicine, Baltimore, and Ophthalmology Times. “Importantly, available information indicates we are currently lacking an accurate method to identify patients at increased risk.”

 

Still Newsworthy PDF Print E-mail

University partners with industry to assist patients injured by Lasik
Read More

Lasik risks understated – Read More

Washington Post Articles – Read More

The American Academy of Ophthalmology says that very short-sighted people “should not have” LASIK eye surgery
Read More

Prevention may be best strategy for managing post-LASIK dry eye
Read More

More LASIK related articles from Ophthalmology Times (Type in LASIK in search box)
Read More

A new study by US researchers reveals that as many as one in five LASIK patients need a second treatment
(May, 2003) – Read More

 

Palmer Awarded Damages After Failed Eye Surgery PDF Print E-mail
A Palm Beach, FL County jury sided with Hall of Fame pitcher Jim Palmer yesterday, finding an ophthalmologist liable for damage to Palmer’s vision and awarding him $890,000.

His attorney, Gary Cohen, said Palmer was talked into a getting a multifocal intraocular lens in his eye that isn’t made for people who work at night. That lens was later taken off the market, Cohen said.

After the cataract surgery, there were signs of retinal tears that should have prompted further examination but were instead ignored and led to a detached retina, Cohen said. Palmer still suffers from vision problems that have affected his ability to work, as many games are held at night.

Undergoing a reattachment surgery was “pretty scary,” Palmer said, not knowing whether he would be able to see when the surgery was over.

The jury awarded $327,000 in lost earnings and $563,000 in past and future pain and suffering.

The full story can be found
HERE

 

LASIK volume up more than 25%, ASCRS survey finds PDF Print E-mail


SOURCE

WASHINGTON — The volume of LASIK procedures grew 26% from 2003 to 2004, according to an annual survey of practice preferences presented here at the American Society of Cataract and Refractive Surgery meeting.

Other notable findings of the survey of U.S. members of ASCRS included an overwhelming preference for acrylic IOLs, a unanimous interest in accommodating IOLs and a near-doubling of the use of clear corneal incisions from 5 years ago.

David V. Leaming, MD, sent his annual survey on general ophthalmic trends to 6,296 physicians; 773 returned the questionnaire. He reported the results of the survey here in a presentation and a poster.

According to Dr. Leaming, in 2004, 62% of survey respondents used topical plus intracameral anesthesia in cataract surgery.

Over a 5-year period, from 1999 to 2004, the use of clear corneal incisions almost doubled, from 40% to 72%, according to survey responses. Surgeons said they prefer a metal blade to a diamond blade by a two-to-one ratio, Dr. Leaming reported.

As in recent years, acrylic IOLs remained the preferred IOL material among respondents, followed by silicone, PMMA and hydrogel. More than half the respondents — 57% — said they prefer a single-piece foldable IOL

For use with ultrasmall-incision cataract surgery in the future, 38% of respondents said an acrylic lens is the most promising IOL, and 29% of respondents said an injectable lens material holds the most promise.

In a change from last year, 61% of respondents said they prefer implanting a clear IOL rather than a blue-light-filtering IOL. In 2003 47% reported preferring clear lenses.

The survey also addressed refractive surgery topics. As noted above, respondents reported an increase in LASIK volume by 26% in the year since the 2003 survey.

Seventy-five percent of respondents said 250 µm is the threshold for the residual stromal bed below which they would not perform LASIK.

Asked about what refractive procedures they were interested in adopting, 84% of respondents said they were not interested in scleral expansion, 49% were not interested in conductive keratoplasty, 54% were not interested in LASEK and 50% were interested in phakic IOL implantation.

Respondents said they charge an average $500 additional to perform customized LASIK over their fee for conventional LASIK.

Dr. Leaming noted that in 2003 respondents said only 9% of patients were offered wavefront LASIK. In 2004, every patient was offered the option of wavefront, he said.

The survey respondents reported an overall post-LASIK ectasia rate of 9%.

Regarding glaucoma, the survey posed a series of scenarios and asked what drug the respondents would prescribe. For first-line therapy in a 45-year-old patient, 60% said they would prescribe prostaglandins if the patient was blue-eyed with no cardiopulmonary complications, and 77% would prescribe prostaglandins if the patient had brown eyes and no cardiopulmonary complications. For a blue-eyed patient with a history of cardiopulmonary complications 83% would prescribe prostaglandins, and for a brown-eyed patient, 94%.

Regarding medical liability, 17% of respondents said they pay a malpractice insurance premium of $10,000 per year; 14% each said they pay $7,500, $12,500 or $15,000.

 

Will New FDA Approval Spur NSAIDs Interest? PDF Print E-mail

Using NSAIDs during the preoperative period can reduce postop pain and inflammation and can provide better visual outcomes.

Michelle Stephenson, Contributing Editor

Vol. No: 12:06Issue: 6/15/2005

IN LATE MARCH, THE U.S. FOOD AND DRUG ADMINISTRATION approved the new drug application for Xibrom (bromfenac ophthalmic solution 0.09%, Ista Pharmaceuticals) for the treatment of ocular inflammation after cataract surgery. Xibrom will be launched in the United States this summer.

Currently available ophthalmic nonsteroidal anti-inflammatory drugs include three formulations of Acular (ketorolac tromethamine, Allergan), Ocufen (flurbiprofen sodium, Allergan), and Voltaren (diclofenac sodium, Novartis), and these drugs are widely used after both cataract and refractive surgery.

The pre- and postoperative use of NSAIDs can help to ease pain and inflammation and can accelerate the return of visual acuity in cataract surgery patients. Additionally, use of NSAIDs keeps pupils dilated during surgery, which allows for quicker and less traumatic procedures.

“Other indications in cataract surgery include the prophylaxis of cystoid macular edema, control of pain associated with clear-corneal cataract incisions, and the improvement of quality of vision after cataract surgery,” says Calvin W. Roberts, MD, clinical professor of ophthalmology at Weill Medical College of Cornell University, in New York City. “The other main indication for the use of NSAIDs is in refractive surgery to control pain after surface ablation and after incisional corneal surgery. I can’t think of any other class of medications that is effective for doing so many things.”

NSAIDs’ Mechanism of Action

NSAIDs inhibit the metabolic pathways of prostaglandin synthesis, which controls inflammation and pain after both cataract and refractive surgery. Intraoperatively, patients who have been given NSAIDs have less blepharospasm and discomfort.

“With cataract surgery, one of the main advantages of nonsteroidals is that they inhibit the prostaglandin release that causes pupillary miosis, and they are very effective at maintaining mydriasis,” says Eric D. Donnenfeld, MD, an associate professor of ophthalmology at New York University Medical Center, New York City.

Dr. Donnenfeld recently conducted a study to assess the clinical benefit, relative efficacy, and dose response curve of preoperative Acular LS (0.4% ketorolac tromethamine ophthalmic solution, Allergan) as a surgical tool in cataract surgery. He presented the study results at the annual meeting of the American Society of Cataract and Refractive Surgery in Washington, DC.

The double-masked study included 100 patients who were randomized into four groups. Three groups received Acular LS before cataract surgery: three days, one day, or one hour preoperatively. The fourth group received placebo.

The effect of Acular LS on maintaining preoperative mydriasis, phacoemulsification time and energy, operative time, corneal clarity, pachymetry, endothelial cell counts, postoperative inflammation, intraoperative and postoperative discomfort, intraoperative complications, and cystoid macular edema were evaluated.

The study found that the maintenance of pupil size, phacoemulsification time and energy, operative time, corneal clarity, postoperative inflammation, and intraoperative and postoperative discomfort was significantly improved with three-day NSAID pretreatment compared to one-day pretreatment, and one-day pretreatment was significantly better than one-hour pretreatment or placebo. In fact, Dr. Donnenfeld says that patients who received Acular LS for three days preoperatively had almost 2 mm more pupillary dilation during cataract surgery compared to placebo.

“In addition, there was a trend toward improved pachymetry on postoperative day one and endothelial cell counts at three months in the three-day pretreatment group relative to placebo. The use of NSAIDs significantly improves patient rehabilitation postoperatively, so that patients see better faster and have fewer postoperative complications,” he says.

According to Henry D. Perry, MD, prostaglandins occur naturally in the eye and are constantly being formed. “Using an NSAID three days before cataract surgery significantly decreases the amount of prostaglandins in the eye. So, when the incision is made, there will be less of an inflammatory response, just because there are fewer prostaglandins in the eye,” says Dr. Perry, who is an associate clinical professor at Weill Medical College.

He also notes that NSAIDs help to lessen patients’ response to painful stimuli because of their anesthetic and analgesic effects. Postoperatively, they are additive to corticosteroids for decreasing inflammation.

NSAIDs have also been found to help patients achieve better contrast sensitivity and better quality of vision after cataract surgery. “The use of nonsteroidals preoperatively and postoperatively will decrease the amount of inflammation that occurs after surgery, and this is directly related to the quality of the vision that the patient achieves,” Dr. Roberts says.

In his recent study, also presented at the ASCRS meeting, 200 patients undergoing routine phacoemulsification were randomized to receive Acular LS along with postoperative steroids and antibiotics, or to receive only postoperative steroids and antibiotics. Macular thickness was measured by optical coherence tomography prior to surgery and one month postoperatively, and contrast sensitivity was measured one month postoperatively. The study found that the incidence of postoperative macular edema was higher in the group that did not use Acular LS and that contrast sensitivity was decreased in the group that did not use Acular LS.

“We concluded that the use of topical NSAID drops can reduce macular edema and improve contrast sensitivity in routine phacoemulsification, and contrast sensitivity is a better indicator of quality of vision than visual acuity after cataract surgery,” he says.

Comparing NSAIDs

Dr. Roberts says that the currently available NSAIDs can be differentiated by potency. Acular and Voltaren are more potent than Ocufen. “In fact, there is really no indication for the use of Ocufen,” he says.

However, although Acular and Voltaren are potent NSAIDs, these drugs have side effects. For example, both Acular and Voltaren sting and burn on instillation. According to Dr. Donnenfeld, diclofenac’s adverse-event profile includes transient stinging and burning in approximately 15 percent of patients with up to 28 percent of patients developing keratitis, and ketorolac has an even higher rate of stinging and burning, with up to 40 percent of patients who use the old formulation experiencing discomfort.

The incidence of burning and stinging has been significantly reduced with Acular LS. “This may sound like a small thing, but when patients use these drops for a long time, stinging becomes a big issue. Acular LS gives us the best of all worlds. It is just as effective as the 0.5% formulation, it is more comfortable, and it is more convenient because it comes in a big bottle,” Dr. Roberts says.

He noted that some refractive surgeons prefer Acular PF (preservative-free) because they want to minimize the amount of preservatives in the eye after cataract surgery. However, he noted that the concentration of preservative in Acular LS is extremely low.

“NSAIDs are safe drugs that have received some bad press, especially Voltaren, because of corneal complications related to the use of the drug topically in dry-eye patients. There is some concern about using NSAIDs in patients with very dry eyes, such as those with keratoconjunctivitis sicca, which is justified. However, for the most part, this class of drugs is very safe for topical use,” Dr. Perry says.

Both Acular and Voltaren are indicated for four times daily dosing for 14 days after cataract surgery to achieve a decrease in postoperative inflammation.

Xibrom

Dr. Donnenfeld was a Phase-III investigator for Xibrom, and he presented results of two Phase III studies at the ASCRS meeting. The studies evaluated the efficacy and safety of Xibrom compared with placebo dosed twice daily for 14 days after cataract surgery with a 14-day follow-up for safety.

The study included 527 patients with a summed (cells + flare) ocular inflammation score of more than three following cataract surgery, in the absence of any anti-inflammatory medication. These patients were randomly assigned to bromfenac or placebo. Treatment was initiated 16 to 32 hours after surgery, and patients were assessed on days three, eight, 15, 22 and 29 after surgery. Ocular and systemic safety was assessed throughout the study.

Of the 527 study participants, 356 were treated with bromfenac, and 171 received placebo. Bromfenac was effective within three days of surgery. In the bromfenac group, 8.4 percent of patients had a summed ocular inflammation score of 0 on day three compared with 1.2 percent of patients in the placebo group. This difference was statistically significant. The proportion of bromfenac subjects with a summed ocular inflammation score of 0 increased at each visit and remained statistically significant through day 29.

According to the study results, 52 percent of patients who received bromfenac had an anterior chamber cell score of 0 on day eight, compared with 30 percent of patients given placebo. On day 15, 76 percent of bromfenac patients achieved this score, compared to 42 percent of placebo patients.

In terms of reduction of post-surgical inflammation, 85 percent of bromfenac patients had marked reduction by day 15 compared to 53 percent of patients given placebo. Additionally, placebo patients had more ocular adverse events.

“We found that Xibrom significantly decreased inflammation at three days, one week, and two weeks after surgery,” he adds.

Xibrom has been approved for twice-daily dosing, and Dr. Donnenfeld believes that this will improve patient compliance. “A topical NSAID with a twice-daily dosing regimen has the potential to enhance treatment compliance while maintaining clinical efficacy,” Dr. Donnenfeld says. “The twice-daily regimen will reduce the frequency of drug exposure and exposure to preservative.”

According to Timothy R. McNamara, PharmD, Xibrom has been approved for twice-daily dosing because of its potency.

“It is a more potent COX-2 inhibitor than other NSAIDs, and very little sting or discomfort is associated with its administration,” he says. Dr. McNamara is director of medical affairs at Ista Pharmaceuticals, Irvine, Calif.

He emphasizes that the FDA required a more stringent endpoint of using a sum score of zero for cells and flare as the primary endpoint in the Phase III studies, and he notes that the researchers achieved that endpoint to a statistically significant level by the 14th day of therapy.

Drs. Donnenfeld and McNamara say that more Xibrom studies will be conducted. Xibrom has not been compared to Voltaren and Acular in the United States, and it has not been studied in refractive surgery patients in the United States.

Xibrom has been used in Japan since 2000, however, and Dr. Donnenfeld says that it has been used in refractive surgery patients there. Dr. McNamara notes that more than 2.7 million patients have received Xibrom in Japan and that it has been compared to other NSAIDs on the market in Japan. “Researchers there have found that it is a much more potent inhibitor of both COX-1 and COX-2, especially COX-2, when compared to diclofenac,” Dr. McNamara says.

Dr. Perry notes that it is twice as potent as Voltaren for inhibiting COX-1 and almost four times as potent for inhibiting COX-2, and COX-2 is the more important enzyme in terms of inhibiting prostaglandin formation.

Addressing Safety Concerns

Some surgeons have questioned the safety of using Xibrom in cataract surgery patients. The oral version of bromfenac sodium was approved by the FDA in 1997, but was voluntarily withdrawn from the United States market approximately a year later following reports of hepatic toxicity when the drug was taken for periods of time exceeding the dosing maximum of 10 days.

However, according to Dr. Donnenfeld, “clinical data from Japan demonstrated that topically administered bromfenac ophthalmic solution 0.9% did not produce plasma concentrations of bromfenac that would be quantifiable using immunofluorescent assay methods with a sensitivity of 50 nanograms/ml. So, the hepatic toxicity potential for topical bromfenac at the doses and duration of therapy for the treatment of post-cataract surgery ocular inflammation is negligible.”

 

Illuminating Facts About Laser Pointers PDF Print E-mail
As posted in FDA Consumer magazine and obtained from

http://www.fda.gov/fdac/features/2005/305_laser.html

May/June 2005

Issue By Linda Bren

Instructors use them to draw attention to information on slide shows. Astronomers use them to point out stars, planets, and other heavenly bodies. And construction workers use them to level and align pipes.

These are all legitimate uses of laser pointers, says the Food and Drug Administration, which regulates lasers and other radiation-emitting devices. But the agency is concerned about the misuse of these potentially dangerous devices and their increased availability for purchase on the Internet.

Laser pointers are misused when they are directed at people or treated as toys. The light energy from a laser pointer aimed into the eye can be more damaging than staring directly into the sun. And the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car, a pilot in a plane, or even a person holding a cup of hot coffee. According to the Laser Institute of America, one woman reported how other mothers she knew bought laser pointers for their children so they could imitate Star Wars characters Luke Skywalker and Darth Vader.

“Laser pointers have become consumer novelty products and promoted as toys,” says Jerome Dennis, a consumer safety officer for the FDA’s Center for Devices and Radiological Health (CDRH). “They’re hazardous as toys and shouldn’t be used frivolously.

“The agency is concerned about the increased availability through the Internet of a variety of laser products that may be illegal or unsafe. Some laser products are intended for use only by professionals or other trained operators. And green laser pointers have the agency particularly concerned. While there are legitimate uses for these green pointers, they may be altered to become more powerful and unsafe if not used responsibly.

“These overpowered pointers may have been modified to emit more radiation than the manufacturer’s original product,” says Lt. Cmdr. Sean Boyd, M.P.H., head of the electronic products branch in CDRH, “and they are not compliant with our standard.” The FDA sets safety standards that must be met before laser products, including pointers, can be legally sold in the U.S. market.

“The potential for injury increases as you increase the power output of the product,” adds Boyd. “Certainly the potential for distraction or flash blindness or startling increases as well when you’re talking about an overpowered green pointer.

“Flash blindness is a temporary loss of vision that occurs when the eye is suddenly exposed to intense light–even from an unintentional sweep of laser light across a person’s eyes. The effect can last from several seconds to several minutes. Recent reports of flash blindness in pilots from laser lights beamed at aircraft have further heightened the agency’s concerns.

The FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent these unsafe products from being sold in the United States.

FDA’s Authority

The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine. And under the Electronic Product Radiation Control Provisions of the act, the FDA regulates both medical and nonmedical lasers such as those used to solder circuits in factories, to scan groceries in a supermarket, or to entertain a crowd with a light show in the night sky.

The FDA may inspect manufacturers of laser products and require the recall of products that don’t comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a display so that the agency can inspect it if possible and take action if required. In 1995, the FDA, working with the Federal Aviation Administration, issued a moratorium that remains in effect on outdoor laser light shows in and near Las Vegas. The action, which affects Clark County, Nev., was taken after airline pilots reported experiencing temporary visual impairment during flights into or out of the county’s three airports.

The FDA requires that labeling on most laser products contain a warning about radiation and other hazards and a statement certifying that the laser complies with FDA safety regulations. The label must also state the power output and the hazard class of the product.

The FDA recognizes four major hazard classes (I to IV), including two subclasses (IIIa and IIIb), of lasers–ranging from those that pose no known hazard to those that pose serious danger if used improperly. The higher the class, the more powerful the laser. Class I laser products, for example, include laser printers and CD players, which are not considered hazardous because the laser radiation is contained within the product.

Class IIIb and class IV laser products are very powerful and permit ready access to the laser radiation, which can cause eye or skin injury. Research and industrial lasers and laser light show projectors fall into these classes. Class IIIb and class IV laser light show projectors may be sold only by or to individuals or firms that have obtained approval from the FDA.

Buyer Beware

In addition to potentially harming your health, some high-powered pointers can damage your wallet, says Dennis. Consumers who purchase an illegal laser product on the Internet–whether knowingly or unknowingly–may lose their money if the product is manufactured outside the United States, he says. “There is a reasonable risk of having a charge laid against your credit card for goods you’re not going to receive because they’re going to be blocked by U.S. Customs and Border Protection.”

What Consumers Can Do

1. Never aim or shine a laser pointer at anyone.

2. Don’t buy laser pointers for your children.

3. Before purchasing a laser pointer, make sure it has the following information on the label:

o a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)

o the manufacturer or distributor’s name and the date of manufacture

o a warning to avoid exposure to laser radiation

o the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

For More Information

If you have questions about a laser product you are considering purchasing or offering for sale on the Internet, contact the FDA’s Center for Devices and Radiological Health at (240) 276-0326.

To report Web sites that you suspect are illegally selling laser products, follow the instructions at

www.fda.gov/oc/buyonline/buyonlineform.htm

See additional information about buying regulated products online at

www.fda.gov/oc/buyonline/

 

Another One Bites The Dust – LASIKPlus Sold

Feb 19, 2014

Once LASIK eye surgery was all the rage. Then TLC, the largest LASIK vision center, went bankrupt. Apparently, it could not run its conveyor belt fast enough to turn a profit.

Yesterday, LCA-Vision, doing business as LASIKPlus, announced it is selling itself for $5.37/share to a skin care company, PhotoMedex.

According to its financial statements, LASIKPlus has not earned a profit since 2007.

If you ever wondered whether patients choose to have LASIK, or are sold this elective procedure, LASIKPlus trumpets that its marketing costs have dropped from $411 to $392/eye. Imagine being sold an elective surgery that “only” costs your surgeon $800 to market.

What does PhotoMedex see in this dog? An underutilized factory. According to its press release, PhotoMedex observes:

LASIK procedures, however, are typically performed only one or two days a week in a costly infrastructure while other days are devoted to patient screening, pre-operative and post-operative care. LASIKPlus centers and staff, who deal one-on-one with patients, are ideally suited for expanding procedures beyond LASIK to include XTRAC laser treatments for various dermatologic disorders such as psoriasis and vitiligo, as well as utilizing the patient interaction for additional clinical brand dispensing.

Imagine the synergies. Two-for one. Treat your myopia and psoriasis in one convenient sitting. What could possibly go wrong?

LASIKPlus was not known for its attention to quality. It received Warning Letters from the FDA concerning violations of federal regulations which govern the proper use of its surgical lasers. It reports more than $6,600,000 in reserves to cover its patients’ medical malpractice claims. That is, at an average price of $3,000 per patient having LASIK surgery on both eyes, it needs 2,200 new patients just to cover the costs of its prior blunders.

I am happy to see LASIKPlus disappear. But it seems unlikely that its new corporate parent will have any more incentive to promote patient safety over patient profit.

Both LASIK patients and investors should look elsewhere.

Coming Out: LASIK Eye Injuries

Sept 25, 2013

Last month, MLB.com reported that Philadelphia Phillies outfielder, Casper Wells, became fearful of getting injured because of post-LASIK vision complications. Since his surgery in November 2012, Wells suffered from chronic dry eye and blurry vision. I do not know Casper Wells, but I imagine he suffers from glare and halos under the stadium lights too. Our client, Tom Baird, is a Phillies fan, who has post-LASIK ectasia. This is what the outfield at Citizens Bank Park looked like to him before he required a corneal transplant.

 

I was thinking about Casper Wells, and his reported $500,000 annual salary, when I read a recent article in The New York Times, “Quandary of Hidden Disabilities: Conceal or Reveal?” I am confident that Wells is not the only professional athlete who suffers career threatening vision complications as a result of LASIK surgery. I have consulted personally with another professional baseball player. Who wants to complain? Who wants to raise doubts? Who wants to jeopardize his or her lucrative contract?

The issue is not limited to professional athletes. It includes people from all walks of life, including health care workers, doctors, pharmacists, people who work in finance, military personnel, pilots and truck drivers. These individuals, like Casper Wells, try to balance their performance against obvious safety concerns. None look disabled. None want to take disability benefits. None want to be discriminated against by their employers or co-workers. Consequently, few ask for workplace accommodations, even though such accommodations would be of certain benefit.

How many patients have LASIK complications? Until more courageous people like Casper Wells come forward, we will never know. Most just suffer in silence.

LASIK Patient Dissatisfaction

Dec 6, 2013

In a recent episode about risks of LASIK surgery, Dr. Oz cited a Consumer Reports survey, which indicated that only 50% of patients who had LASIK surgery, three year later, were satisfied with their results.

A recent report from Japan’s Consumer Affairs Agency put the patient satisfaction rate at 74%. For a copy of the story reported in Japan Times see here. 43% of patients complained of severe eye pain, dry eyes, and difficulty seeing in dim light. 18% said the surgery did not meet expectations, or that the improvement was only temporary.

The Japanese government report is important in the absence of any action by the F.D.A. More than five years ago, the F.D.A. promised a LASIK safety survey which has yet to come. Curiously, the Japanese experience, like the Consumer Reports survey, demonstrates much more patient dissatisfaction than the LASIK industry acknowledges.

Surgeons Make Thousands of Errors

Jan 8, 2013

A recent article in the Wall Street Journal reports that surgeons make thousands of errors – – that should never happen: operating on the wrong patient; leaving a sponge behind; or in the world of LASIK eye surgery, putting the wrong numbers in the surgical laser.[1]

We have two of those cases. We also have dozens of inquiries from patients who have vision-threatening post-LASIK ectasia, caused by eye surgery which never should have been performed in the first place. Unlike some complications in medicine, these surgical mistakes, for an elective procedure, are totally preventable, and should never happen.

[1] See Laura Landro, “Surgeons Make Thousands of Errors,” Wall Street Journal, December 20, 2012, p. A2.

Top New York Settlements of 2012

SOURCE

Once again, the Law Office of Todd J. Krouner has achieved one of the top settlements of the year for LASIK malpractice. According to Verdict Search, in 2012, our $975,000 recovery for a Staten Island housewife with ectasia was among the largest medical malpractice settlements, and the only reported recovery for a LASIK surgery mishap.

According to a report by Ophthalmic Mutual Insurance Company, the average recovery for successful LASIK surgery negligence claims is less than $100,000.[1] Consequently, choosing a knowledgeable attorney, with experience handling LASIK, and related eye surgery, malpractice cases, is critical to not only having a successful outcome, but also to obtaining full compensation for vision threatening injuries.

If you or a loved one has been injured by a doctor, you should promptly contact an attorney with experience in medical malpractice. The Law Office of Todd J. Krouner has a proven track record of helping patients injured by LASIK (and other forms of medical malpractice) all over the country. To determine if you have a strong case, contact us for a free consultation at (914) 238-5800.

[1] See James D. Salz, M.D, “Lawyers, Guns, Money, & Medicine,” Cataract & Refractive Surgery Today, February 2007, p. 61.

Chinese Doctors Recommend Against LASIK For Military Personnel

Posted April 17, 2012 julia

I just returned from an extraordinary two week trip to Asia. Last month, the top LASIK surgeon in Taiwan quit performing the procedure after noticing alarming complication rates in his patients several years later.

This month, another team of Chinese ophthalmologists reported that LASIK is not safe for military personnel. The report in the Chinese Journal of Traumatology concluded: “There is a high risk of potential flap problems after LASIK and it is not recommended in army service.”

Newly four years have elapsed since the FDA promised LASIK safety studies. For those who are tired of holding their breath, the recent news from Asia is not encouraging.

New Questions About LASIK Safety

Posted February 27, 2012 julia

Earlier this month, Tsai Jui-Fang, M.D., the ophthalmologist who had introduced LASIK surgery to Taiwan approximately 20 years ago, quit the procedure because of safety concerns. Related Chinese medical device stocks reportedly dropped 4% the following day.

Dr. Tsai reported that some of his patients experienced serious eyesight deterioration for unknown reasons around 10 years after surgery. He suspects that the problem may have been caused by chronic postoperative inflammation underneath the corneal flap.

In response, the Ophthalmological Society of Taiwan maintains that LASIK surgery is a low-risk procedure, with a complication rate less than 0.1 percent. That number is not credible.

In the United States, Morris Waxler, who approved the surgical lasers for LASIK when he worked at the FDA in the 1990’s, has petitioned the FDA for a moratorium on LASIK surgery. Dr. Waxler says, “If I knew then, what I know now, I never would have recommended approval of these lasers.”

In 2008, the FDA held hearings on LASIK safety. Four years later, we continue to await its report on LASIK safety.

Minnesota Court Refuses to Dismiss Claims of Malpractice Against LASIK Surgeon

Posted February 24, 2012 julia

On February 10, 2012, a Minnesota court denied summary judgment, and refused to dismiss claims of malpractice against LASIK surgeon, Mark Lobanoff, M.D. Linegar v. Lobanoff, Civ. Action No. 10-4956 (D. Minn). In that case, the complaint alleged that the doctor committed malpractice when he performed three surgeries in eleven months, for a total treatment of 8.45 diopters, resulting in her need for a cornea transplant.

The patient also claimed that the doctor breached informed consent when he switched from LASIK to PRK surgery, and allegedly discussed the change in surgical plan, only after he administered 15 mg of valium; and, the doctor violated the Minnesota Consumer Protection Act when he claimed to be the “preferred LASIK surgeon to the Minnesota Vikings.”

By memorandum opinion and order dated February 10, 2012, the court ruled that the patient’s medical expert opined with sufficient detail how the alleged excessive treatments caused the patient’s corneal scar. The court also rejected the doctor’s informed consent arguments:

Defendants contend that Linegar orally consented to the PRK,
but there is no evidence of that in the record.
Dr. Lobanoff testified only that his usual procedure was to discuss the
risks with the patient; he also stated, however, that he had never had a
situation in which a patient refused to open her eyes enough for LASIK, thus
necessitating the operating-room switch to PRK.
Moreover, there is no dispute that Linegar had been mildly sedated so
that any consent she gave would be suspect.
Dr. Lobanoff acknowledged as much by having his staff get a consent for
the PRK from Linegar’s husband in the waiting room.

The court dismissed the consumer fraud claim finding that the patient did not rely on the false advertising. The court was persuaded that the patient had her first two surgeries before the doctor began his deceptive advertising claim. However, the court disregarded the patient’s testimony that she ceased treating with the doctor, treated with another practice group, demanded a refund, and only returned to Dr. Lobanoff after she saw his billboard:

Dr. Lobanoff admitted that he treated no current Vikings players, while the Vikings’ trainer stated that six of his players received treatment from another “preferred” LASIK provider.

In a related motion, defendants’ counsel sought to discharge and replace defense expert George Waring, M.D., as “incompetent,” as a result of “issues with his memory.” Plaintiff opposed the motion, noting that Dr. Waring continues to treat patients, and no medical affidavit was offered to support Dr. Lobanoff’s claim that his own expert was incompetent. Instead, plaintiff argued that defendants sought to fire Dr. Waring because of his unsuitable history as an expert, including his consensual settlement in a hyperopic ectasia malpractice lawsuit filed against him; suspension of privileges from Emory University Eye Center for implanting a surgical device without the patient’s consent; and a criminal conviction for assaulting a flight attendant.

In addition, the court also rejected plaintiff’s argument that as a subsequent treating doctor, it was impermissible for Neal Sher, M.D., to testify as an expert against his former patient. Plaintiff argued that it was a breach of fiduciary duty, and violation of professional ethics, for a doctor to become a paid expert/advocate against a former patient. As a result, patients need not only fear injury by surgeons, but should be prepared for subsequent treating doctors to testify not only as to facts, but as to expert opinions, that impair patients’ ability to seek compensation for malpractice.

As a final point, the court granted plaintiff’s counsels’ motion to withdraw as her attorney.

Doctors Continue Arguing Against LASIK

Posted January 9, 2012 julia

Wednesday December 28, 2011
The Laser Surgery Battle Begins

We’ve always promised to give you updates on our stories whenever they come about. Awhile back, we wrote an Undercoverarticle about the problems with Lasik eye surgery. If you read it, you know that we were able to interview the chief man at the FDA who was in charge of approving Lasik devices. His name is Dr. Morris Waxler…and he recently turned whistle blower on these devices. He says he was deceived into thinking the devices were safe…so he approved them for the public. But he says emerging evidence shows that these devices do more harm than good. We discovered that Dr. Waxler isn’t the only one who has strong beliefs about these devices because we received loads of feedback from our readers. Dr. Stephen Hollis wrote to us after we published the article. He’s a LASIK specialist and he made it clear that he doesn’t agree with Dr. Waxler.

Here’s what Dr. Hollis had to say on the issue:

“I have done 140,000 refractive cases. Many of the problems Dr. Waxler mentioned were at the infancy of Lasik, and it is rare today. Dry eye patients are made a little worse, but only for 6 months, and this is usually treatable, and I do that at no cost to the patient. Glare at night was caused by the VisX laser, the winner of the political wars who supported Senator Ted Kennedy, head of the device arm of the FDA. The FDA is political, but for the opposite reason as stated by Dr. Waxler. It is very rare to have night vision problems with today’s lasers that yield larger optical zones. Dr. Waxler is not righting a wrong, he is sensationalizing something for profit, in my opinion.” We knew we had to look into what Dr. Hollis had to say. So we decided to track down and interview Dr. Waxler again about our reader’s questions and comments:

Here’s how Dr. Waxler responded:

“Excellent article! “Amazing response by the LASIK surgeon. He did LASIK on 140,000 cases at approximately $1000 per eye and accuses me of making a profit by telling truth to power at my expense. Occasionally I earn a few hundred dollars for expert testimony and sometimes nothing. Who has the financial interest? Transparency is another issue. This LASIK surgeon does not cite actual data to demonstrate that there are no vision problems after 6 months on the 140,000 cases. Where is the evidence? The evidence I cite in my petition includes all published data and data submitted from all LASIK devices including the most recent ones approved by FDA. If this LASIK surgeon is so confident, then he should submit the raw data on the 140,000 for independent scientific scrutiny.” This is such a hot issue that we’re going to continue investigating it further. If you have questions for Dr. Waxler please let us know and we’ll follow up directly with him and other insiders as needed. In the meantime, for people who missed it, read the original article below that stirred up so much response.
LASIK surgery is supposed to fix vision problems. But new evidence shows that one out of five people who have the surgery end up with serious side effects. Recently released information reveals that the surgery can lead to blurred night vision… thinning and bulging corneas…and even blindness. Often, the patient is left with vision issues that are far worse than those they had before surgery. And in many of these cases the damage is long term…sometimes even permanent. Most patients don’t hear about the risks associated with surgery. And most eye doctors don’t tell them. But now a former FDA chief is spilling the beans about the risks of eye surgery. He’s just gone public about how LASIK devices first made it onto the market. He’s showing how the industry distorted data to get FDA approval. And how the FDA failed to ask the necessary questions to make sure the surgery was effective and safe. Join us as we investigate his claims and uncover the true story behind LASIK surgery.

LASIK Surgery Not Always the Safest Pitch

These recent claims don’t come as any surprise to Jay Gibbons. He’s a baseball outfielder for the Los Angeles Dodgers. Gibbons was at the top of his game when he started having sight problems. He tried contact lenses but found they popped out during the game. “We’re going to try to find a better solution,” Gibbons told the LA Times.

Outfielders need to be able to see the ball. Their careers depend it. “We need to get that resolved,” said Dodgers Manager Don Mattingly. “If you don’t have your depth perception right on, trying to hit a breaking ball just doesn’t work.” So Gibbons was left with no choice. He had to do something and he turned to LASIK surgery. It seemed like the perfect solution…and he was assured that it was a safe, easy and quick way to restore his game. “Hopefully, by Thursday this is a non-issue,” he said prior to the surgery.

So he went through with it. And that’s when his problems really began. After the surgery, his game went from bad to worse. He experienced blurred vision and couldn’t see well enough to play. Each successive year his game went down. Finally, during the 2010 season, he was placed on the team’s disabled list. This year he’s appeared in a career-low number of games. While he’s more high profile than most, Gibbons is by no means the only person to be affected by LASIK surgery. In fact 20 percent of all cases result in serious complications. Now a former FDA official is revealing why there are so many problems with this surgery.

Dr. Waxler Tells All

The whistleblower in this case is Dr. Morris Waxler. He’s a retired FDA official. And now runs his own consulting firm called Waxler Regulatory Consultancy, LLC. Dr. Waxler didn’t only work for the agency when LASIK devices were approved in the 1990s. He was chief of the branch responsible for the approval. He managed a team of technical experts. They reviewed studies submitted by LASIK companies. Then Dr. Waxler critiqued the reviews and made recommendations to the Division Director. Now he’s LASIK’s worst nightmare. He filed a petition asking the agency to reverse its decision to approve LASIK devices. He also wants the feds to seize all FDA approved lasers, issue a Public Health Advisory and launch a criminal investigation. Dr. Waxler says the FDA is continuing to mislead the public. They use a graph that shows side effects last only six months. But he says many patients have complained of continuing eye problems for years. Dr. Waxler also notes that the graph was developed by LASIK manufacturers. He has asked the FDA to remove it. But they continue to use it. In an exclusive NHD interview, Dr. Waxler says he’s speaking out now because he wants to right a wrong. He says patients contacted him after retirement and asked him to do something about the devices that he approved.

So he went to the FDA website and re-analyzed the data. He looked at each table, counted the number of adverse side effects and how long they lasted. He also analyzed peer review literature and compared it with what was submitted to the agency. “What I realized was that refractive surgeons that I admired and that had tremendous reputations were basically playing a game with me,” he says. “They kept information. They minimized certain problems. I assumed that as clinicians they would be honest and straightforward with regard for these problems.” Dr. Waxler says he regrets his decisions back then. But it’s nearly 13 years too late. About 15 million people have already had LASIK surgery. And many are suffering the consequences.

The Eye of the Storm

LASIK is short for “laser-assisted in situ keratomileusis.” It’s supposed to correct nearsightedness, farsightedness and astigmatism. Surgeons slice a flap in the eye. And they use a laser to reshape the cornea. More and more people are opting for the surgery. That’s because they don’t want to wear eyeglasses and contacts. The FDA first approved the use of the exicmer laser for eye surgery in 1995. The early surgeries used the laser to change the surface shape of the cornea. It’s a type of surgery called a PRK. Then in 1992 surgeons developed the LASIK version…that surgery involved reshaping the cornea under the surface. And the first LASIK device was approved in 1998. In 2007, the FDA recalled Alcon LADARVision 6000 excimer lasers. That’s after some patients experienced complications. The next year, more than a dozen LASIK patients and their families testified before an FDA panel. They shared horror stories about the surgery. They said doctors did a poor job warning them. And they were unaware that vision loss and eye dryness could occur. Todd Krouner is a New York attorney. He represented several patients at the time. Among them was the wife of a former police officer. She says the side effects caused her husband to take his own life. At the end of the hearing, the panel said the FDA should do more to warn patients of the risks. After a 2010 Good Morning America LASIK news report, the FDA released the following statement:

The FDA is concerned about reports of patient problems post-LASIK. The agency has established and promoted better mechanisms for reporting adverse events, update information on our Web site to better communicate the risks and benefits of this surgery and to better monitor and improve the safety and effectiveness of the lasers used in the LASIK surgery.

The agency also said it had taken steps to better understand the potential risks. It wanted to help patients, manufacturers and health care providers avoid them. Last year, the FDA issued a letter warning LASIK providers against “false and misleading advertising” regarding the surgery. And the FDA Office of Compliance has inspected several LASIK facilities. It has found “inadequate adverse event reporting systems.” The agency is also launching a national study on post-LASIK problems. It’s being done in collaboration with the Department of Defense and the National Eye Institute. But it’s too many years and too many people too late. And the devices still remain on the market. People are getting LASIK surgery every day. Many have no idea that it could make their sight worse. And the FDA is acting too slowly…at least for people like Abby Ellin. She’s a New York journalist. And she had LASIK in 2007. She suffered from halos, dry eyes and other side effects. And three years later they still persist. Ellin told her doctor…but nothing was done. Her doctor told her “it will go away.” But Ellin says “it didn’t go away.”

Three years later, she’s one of many who are still suffering the consequences of laser surgery.

20/20 Hindsight

Dr. Waxler argues that LASIK should have never been approved. He says the agency relied on industry studies for safety information. And the data showed that the:

  • The adverse effect rate was one percent when it was really 20 percent.
  • The adverse effects were temporary when they were persistent for six months or more.
  • The effectiveness rate was greater than 90 percent when it was only 57 percent.

“If I was completely aware of what was going on, I would have recommended disapproval,” he says. Dr. Waxler says the FDA is a flawed agency. And it needs to be fixed. “Congress over the years has developed an approval structure for devices that puts the agency in a very awkward position,” he says. “It’s a system that favors the manufacturers. It does not favor the public.” Now the LASIK industry is hitting back. The American Society of Cataract and Refractive Surgery have issued a statement. They commended Dr. Waxler for his commitment to LASIK safety. But they also disagreed with his “science and conclusions.” “The vast preponderance of clinical evidence shows that Lasik is safe and effective – a conclusion that the FDA has repeatedly re-affirmed in its multiple reviews of up-to-date information,” they wrote. “By failing to follow standard protocol, Dr. Waxler does a disservice to all LASIK patients – including those few who have had serious problems and who deserve to have them clearly understood.”

The industry has published their own studies that contradict Dr. Waxler’s findings. They suggest a 95 percent satisfaction rate among patients. But Dr. Waxler says those statistics are misleading. They’re based on an assumption that patients who don’t come back to complain are satisfied. And that’s not always true. In his petition, he provides scientific research that shows an adverse event rate of 22 percent. He says manufacturers pressured the FDA not to classify symptoms like glaring, halos, dry eyes and night driving problems as just symptoms. Not adverse side effects. And that enabled them to meet the FDA’s adverse event approval rate of less than one percent.

Financial Interests

So why is LASIK surgery even on the market? Dr. Waxler believes it all comes down to money. LASIK has grown into a $16 billion industry. And nearly 700,000 surgeries are done each year. “It’s a game that the manufacturers and surgeons are playing because they get paid an enormous amount of money to take a few minutes to cut a person’s eye and so-call reshape it,” says Dr. Waxler. Best-selling author Michael Lewis agrees. In his book, The Big Short, he describes the evolution of the LASIK industry. He calls it the cash cow that’s replaced cataract surgery. Medicare reimbursements for cataracts dropped from $1,200 to $450. And he says LASIK surgery has helped the medical industry replace the lost income.

Natural Alternatives for You

Even if you have vision problems, you don’t have to be part of the money game. There’s a lot you can do right now to improve your sight…and it won’t require surgery. This month’s issue of our Natural Health Dossier newsletter will focus on vision. It will be packed with all-natural solutions and alternative methods to help your eyes. You can also view our new article on two dietary nutrients that reduce the risk of eyesight loss by 43 percent.

So take a look, and stay tuned for our upcoming newsletter. In the meantime, NHD will continue to report the best health solutions for you and your family.

Wishing you good health,

Ian Robinson
Editorial Director, NHD “Health Watch”

 

Dr. Owczarek Sued For LASIK Surgery Malpractice

Posted October 5, 2011 julia

PRESS RELEASE – FOR IMMEDIATE RELEASE

Thomas Baird v. Frank R. Owczarek, M.D. and Eye Care of Delaware, LLC

In the Superior Court of the State ofDelaware, Case No. N11C-09-241 RRC

  1. OWCZAREK SUED FOR LASIK SURGERY MALPRACTICE

On September 3, 2011, Thomas Baird filed a complaint against Frank R. Owczarek, M.D., and Eye Care of Delaware, LLC, in the Superior Court of the State ofDelaware, for the negligent performance of LASIK surgery.

In January 2004, Dr. Owczarek performed LASIK surgery on both of Mr. Baird’s eyes. The complaint alleges that after the initial surgery failed, leaving Mr. Baird with visual acuity worse than 20/50 and 20/60, in his right and left eye, respectively, Dr. Owczarek proposed additional surgery on October 14, 2009. However, during the patient’s pre-enhancement eye examination, Dr. Owczarek failed to see signs of ectasia, for which LASIK surgery is contraindicated. As a result, Mr. Baird is now legally blind in his left eye, and vision in his right eye is significantly worse than it was before the surgeries.

Ectasia is a disorder that causes progressive thinning and weakening of the cornea. Patients with ectasia often suffer a loss of visual acuity. In addition, individuals may suffer from a host of problems related to the quality of their vision, which include halos, blurry vision, glare, ghosting, starbursts, double vision, light sensitivity, contrast sensitivity, loss of depth perception, difficulty driving a motor vehicle, especially at night, headaches, dry eyes, and foreign body sensation.

Mr. Baird is represented by the Law Office of Todd J. Krouner in Chappaqua, New York, and Hudson & Castle Law, of Wilmington, Delaware. Mr. Krouner represents victims of LASIK surgery throughout theUnited States. Mr. Hudson has extensive experience in litigating medical malpractice actions.

A copy of the complaint is available here. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Bruce Hudson, Esq., at (302)504-8146.

LASIK Racketeers

Posted December 5, 2011 julia

TLC was once the largest laser eye facility in the United States. Its parent corporation’s stock traded on the New York Stock Exchange, until it recently went bankrupt. However, its bankruptcy did not come soon enough for a large cluster of approximately 60 patients in South Carolina, who developed an avoidable, vision threatening complication, post-LASIK ectasia. In their class action, the patients allege that TLC not only injured them, but also concealed their diagnosis, so that their statutes of limitation would run.

In addition to TLC, the individually named LASIK surgeons include a “who’s who” in the industry, and cover laser centers nationwide, including New York, Chicago, Denver, Atlanta, Boca Raton, Pittsburgh, Cleveland and Madison.

Separate from the medical malpractice claims, the class action alleges that TLC and its doctors engaged in a pattern of racketeering activity by keeping two sets of patient records, and denying patients access to their “true” records, which revealed their diagnosis of vision threatening ectasia.

In a February 2011 decision, the federal court dismissed the racketeering claims because under South Carolina law, patient records are the property of the doctor, and not the patient. In addition, to the extent that some claims were 10 years old, or more, the court ruled that they were barred by the statute of limitation.

Still, the thrust of this shocking lawsuit continues in state and federal court inSouth Carolina. The case is a sad reminder of the worse of the LASIK industry including:

(1) Profits coming ahead of patient care;

(2) Doctor preservation coming ahead of patient vision preservation;

(3) Under reporting and non-reporting of serious vision threatening complications not only to the FDA, but to the patients themselves.

For a copy of the decision, Dickenson v. TLC LASIK Centers, please click here.

LASIK, Money, and Patient Satisfaction

Posted April 22, 2011 julia

In The Big Short, in a chapter ironically entitled “In the Land of the Blind,” best-selling author Michael Lewis describes how doctors respond to bad incentives. He explains “The evolution of eye surgery is another great example.” He writes that LASIK was born when Medicare reimbursements for $1,200 cataract procedures were slashed to $450. Quoting a Vanderbilt trained neurologist, Michael Bury, M.D., “the incentive was to maintain their high [seven figure] incomes, and the justification followed.”[1]

In the news, Morris Waxler, Ph.D., calling on the FDA to pull the plug. He worked for the FDA when the lasers were initially approved. In short, Dr. Waxler says if he knew then what he knows now, he never would have recommended that the FDA approve LASIK.

Responding en masse, the LASIK-Industrial Complex is calling on its titans to trumpet the safety of the current generation of LASIK technology in the hands of skillful surgeons.[2][3][4][5] They say LASIK is the safest surgical procedure known, with patient satisfaction rates ranging from 95 to 98 %.

For the LASIK consumer, the challenge is to find the right surgeon and the right technology. As recently as 2007, Alcon’s LADARVision 6000 surgical laser was quietly recalled by the FDA after hundreds of patients were injured by the product defect. Problems with creating surgical flaps have been reduced by Intralase lasers, which have replaced the prior generation microkerotomes, or miniature meat slicers. Yet, doctors still use microkerotomes. And, while the LASIK industry says the current generation of technology is terrific, where were the warnings for those unwitting “guinea pig” patients who were injured by the prior technology?

In selecting a surgeon, competence and experience help. But what matters more is the surgeon’s business model. Even terrific LASIK surgeons have failed their patients in high volume LASIK factories.

In short, I have three impressions about the current debate between Morris Waxler and the LASIK industry:

  1. I do not support Dr. Waxlerr’s petition to cease LASIK. I know too many honest, intelligent LASIK surgeons, “who eat their own cooking,” to say the surgery is inherently flawed.
  2. Knowing the true risks and consequences of this elective surgery, I choose to stick with my glasses and contact lenses.
  3. For LASIK surgery customers to make their own truly informed decision about the risks, benefits and alternatives to this popular surgery they deserve an independent patient satisfaction study that is free of the influence of the LASIK Industrial Complex.

_____________________________________________________________________________________

[1] Michael Lewis, The Big Short (2010), pp. 43-44.

[2] http://www.youtube.com/watch?v=RfpV89JZNYY

[3] Doyle Stulting article

[4] http://www.cnn.com/video/#/video/health/2010/09/28/nr.lasik.safety.cnn?iref=allsearch

[5] http://www.osnsupersite.com/view.aspx?rid=81833

  1. MARK WHITTEN, DR. L. EDWARD PERRAUT, M.D., & TLC SUED FOR LASIK MALPRACTICE

Posted March 18, 2010 julia

PRESS RELEASE – FOR IMMEDIATE RELEASE

Jamie Domeier vs. Mark Whitten, M.D., L. Edward Perraut, Jr. M.D., TLC The Laser Center
(Northeast) Inc., Jo Angeles, O.D., Andrew Morgenstern, O.D., Greg W. McGrew, O.D., Paul J.
Chmielewski, O.D., and Eyecare Center Of Leesburg, P.C.
Virginia Circuit Court of Fairfax County
Case # CL 2009-2959

  1. MARK WHITTEN, DR. L. EDWARD PERRAUT, M.D., & TLC SUED FOR LASIK MALPRACTICE – On August 7, 2009 plaintiff, Jamie Domeier, served her Complaint against Mark Whitten, M.D., L. Edward Perraut, Jr., M.D., TLC The Laser Center (Northeast) Inc., Jo Angeles, O.D., Andrew Morgenstern, O.D., Greg W. McGrew, O.D., Paul J. Chmielewski, O.D., and Eyecare Center Of Leesburg, P.C., in the Circuit Court of Fairfax County, Virginia, for failing to appropriately manage Jamie Domeier’s post-operative LASIK care.

Ms. Domeier had LASIK surgery at a TLC facility in Ann Arbor, Michigan. Following Jamie Domeier’s LASIK surgery, she was instructed to return to northern Virginia for her post-operative care. During that post-operative care, Ms. Domeier was bounced around among various eyecare professionals including, but not limited to, four optometrists and two ophthalmologists, including Defendant Mark Whitten, M.D. Defendant Mark Whitten, M.D. was Tiger Woods’s LASIK surgeon and is the Regional Medical Director for TLC Laser Eye Centers in the Washington, D.C. Metro Area and Richmond, VA.

The Complaint alleges that defendants passed Ms. Domeier from one doctor to another, prescribed steroid eye drops, while no one took charge of her post-operative care, nor carefully monitored or appropriately responded to the increase in her intraocular pressure, which was caused by the steroids. Consequently, after months of incompetent post-operative care, she was initially seen by a glaucoma specialist who diagnosed her with irreversible and permanent nerve damage to her optic nerves. Ms. Domeier now suffers from steroid induced glaucoma which was caused as a result of the negligence of Defendant TLC, and that of its several eye care professionals, who supposedly “co-managed” her post-operative care.

Ms. Domeier is a 23-year-old salesperson, who had aspirations to perform in the highest level of equestrian competition. However, as a result of the incompetent co-managed care system of the defendants, she is blind in her left eye. Jamie Domeier’s equestrian career has ended, barely before it had begun.

The plaintiffs are represented by Todd J. Krouner, from Chappaqua, New York, and Donna Miller Rostant, of Jones & Rostant, P.C., from Fairfax, Virginia. Mr. Krouner and Ms. Rostant represent victims of LASIK surgery throughout the United States.

How Safe is LASIK? The Tiger Woods of Medical Procedures?

Posted February 1, 2010 julia

February 1, 2010

In a recent article, New York Times reporter Abby Ellin writes that Army doctor Erik J. Rupard, refers to LASIK as “the Tiger Woods of medical procedures: deeply and demonstrably flawed, but so many people love it that the few of us who speak ill of it are dismissed as cranks and/or loonies.” Dr. Rupard’s assessment is based on the volume of dry eye complaints he witnessed in soldiers serving in Iraq.

More alarming still, is the admission of Morris Waxler, who as former branch chief of the FDA’s Center for Devices and Radiological Health Office of Service and Technology, was responsible for the FDA’s approval of the first lasers in 1998. Mr. Waxler says: “We screwed up…We should have looked at the worst-case impact on patients, rather than just the very good outcomes we saw in the clinical trials.”

Abby Ellin, who previously wrote of her own poignant LASIK regrets, reports that the LASIK industry disagrees with Dr. Rupard, and maintains that LASIK is among the safest elective procedures ever devised. Millions of satisfied patients may agree. And, some soldiers may claim that LASIK literally saved their lives, notwithstanding their dry eyes.

Still, for most of us civilians, the decision to have LASIK surgery is rarely a matter of life or death. Hopefully, the recently announced FDA and Department of Defense proposed joint study will give LASIK consumers reliable information about LASIK complications and quality of life issues so that they can make an informed decision whether to have this surgery.

THE STATUTE OF LIMITATIONS AND TIME BOMB OF POST LASIK ECTASIA

Posted December 29, 2009 julia

The statute of limitations refers to the period within which you must start a lawsuit. If you fail to act in timely fashion, a court will dismiss your lawsuit, no matter how strong your claim may have been. Consequently, tardy victims can be left without any legal remedy. The statutes of limitations for medical malpractice vary from state to state in duration (and exceptions). For instance, the statute of limitations in New York is two and one half years, and may be extended, or “tolled”, if you continued treatment with the same physician for the same condition; in New Jersey, the statute of limitations is two years, but may be extended until you discover your injury; in California, the statute of limitations is three years, or one year from discovery of your injury, but in no event can you sue more than three years after the last act of the defendant doctor.

For victims of LASIK eye surgery malpractice, the statute of limitations poses extra perils. Recently, I was contacted by doctor who had LASIK eye surgery at TLC in 2003, when he was living in California. In 2004, he moved to New York, where his subsequent treating ophthalmologist diagnosed him with post-LASIK corneal ectasia in 2009. Ectasia is a progressive thinning of the cornea, which can cause poor visual acuity and poor visual quality. Complaints such as double vision, halos, glare, ghosting, star bursts, blurring, and photosensitivity are common. In this case, the new eye doctor informed his patient that the original TLC surgeon was negligent because the patient was never a suitable candidate for LASIK due to the preoperative condition of his eyes, which included thin corneas and substantial astigmatism. On average, ectasia can take 16 months to develop after LASIK surgery[1]. In this case, unfortunately for the patient, the time bomb of ectasia had a particularly long fuse, and took almost five years to develop, by which time it was too late for the patient to sue his LASIK surgeon, under his unique circumstances.

In short, lawsuits are not like fine wine. Generally, legal claims do not improve with time. Memories fade; witnesses disappear; evidence is lost. If you think you may be the victim of medical negligence, you should seek prompt legal advice. Many potential clients explain that they need to take care of their medical crises before they can even think about a lawsuit. That priority makes sense and is understandable. But it is equally important to at least learn and understand the statute of limitations that applies to your case, so that it does not expire inadvertently.

[1] Randleman, J.B., et al.“Risk Factors and Prognosis for Corneal Ectasia after LASIK.” Ophthalmology 2003; 110:267-275.

  1. WILSON HORSLEY SUED FOR LASIK MALPRACTICE – PRESS RELEASE

Posted March 18, 2009 julia

PRESS RELEASE – FOR IMMEDIATE RELEASE

Nathaniel Chapman and Princess “Shelli” Chapman vs.

Wilson Horsley, M.D., HorsleyEyeCenter, P.C., and Clear Vision Eye Center, Inc.

United State District Court, District of Massachusetts
Case # 1:09-cv-10325-JGD

  1. WILSON HORSLEY SUED FOR LASIK MALPRACTICE – On March 4, 2009, plaintiff, Nathaniel Chapman, filed suit against Wilson Horsley, M.D., Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc., in the United State District Court, District of Massachusetts, for performing LASIK surgery on Mr. Chapman. Mr. Chapman is a 36-year-old army trained respiratory therapist, who resides in New Braunfels, Texas. On March 22, 2002, Mr. Chapman came under the care and treatment of Dr. Horsley for the purpose of having LASIK surgery on both eyes at the Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc. Despite signs of Mr. Chapman’s pre-existing corneal condition, Dr. Horsley performed LASIK surgery. To compound Dr. Horsley’s error, on April 14, 2006, Dr. Horsley performed a second corrective LASIK procedure, euphemistically referred to as an Aenhancement@, on Mr. both of Mr. Chapman’s eyes at Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc. As a result, Mr. Chapman developed post-LASIK ectasia. Consequently, Mr. Chapman’s vision has suffered severely, and he faces a possible corneal transplant.

The complaint alleges, among other things, that Dr. Horsley was negligent in failing to determine that Mr. Chapman was not a suitable candidate for LASIK eye surgery and in performing LASIK eye surgery on Mr. Chapman when said procedure was contraindicated.

The plaintiffs are represented by Todd J. Krouner, from Chappaqua, New York, and Jeffrey N. Catalano of Todd & Weld, LLP, from Boston, Massachusetts. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Catalano has extensive experience in litigating medical malpractice actions.

A copy of plaintiffs’ complaint is available at www.krounerlaw.com. For further information, please contact Todd J. Krouner, Esq., at (914) 238-5800, or Jeffrey N. Catalano, Esq., at (617) 720-2626.

View Complaint: Nathaniel Chapman vs. Wilson Horsley, M.D.

LASIK CO-MANAGED CARE

What Does Co-Managed Care Mean?
In LASIK, “co-management” is the term commonly used to describe a situation when an optometrist provides pre-op and post-op care with an ophthalmologist providing surgery. For example, an optometrist will provide the initial LASIK, All-Laser Lasik, PRK, LASEK or any other refractive surgery evaluation, and then care for the patient after the surgery. The ophthalmologist will merely provide the surgical component. In other words, you won’t be seeing the doctor before or after the surgery.

Proponents of co-management argue that it provides a check and balance between the patient and the surgeon with an optometrist assessing the patient’s questions and concerns. But what patients should understand is that co-management is not about care. It is about economics. It’s mostly about the money. Though they cannot legally perform surgery, optometrists are teaming up with ophthalmologists who can do those surgeries by referring patients for the procedure. Then, they handle the patients’ post-operative and sometimes pre-operative care in exchange for a cut of the fee.

Ophthalmologist or Optometrist: What’s the Difference?

Many people may not realize who they are going to see when they go visit the “eye doctor.” The big difference is that one (ophthalmologist) is a medical doctor whereas the other (optometrist) is not. An ophthalmologist is a medical doctor or surgeon who deals with the structure, function and diseases of the eye. An optometrist is a specialist in the measurement of the range, and power of vision, and in the prescribing of corrective lenses. Once again, an optometrist is NOT a medical doctor.

Who Benefits from Co-Managed Care?
Co-management is still a very controversial area of LASIK. That’s because there are serious ethical issues involved here. The most important issue is that optometrists may in fact be performing the role of a physician – a role they are not qualified to perform. Also, co-management can be hard to distinguish from the illegal practice of “fee splitting.” Optometrists have a choice of ophthalmologist to whom they refer patients, and that decision can be influenced by whether the ophthalmologist is willing to co-manage patients. Overall, co-management is just another way for money to change hands.

One of the largest laser surgery centers in the country, TLC, admits that its co-managed care model may be illegal. In its Annual Report to Stockholders, filed with the United States Securities and Exchange Commission, it states:

Many states prohibit a physician from sharing or “splitting” fees with persons or entities not authorized to practice medicine. The Company’s co-management model for refractive procedures presumes that a patient will make a single global payment to the laser center, which is a management entity acting on behalf of the ophthalmologist and optometrist to collect fees on their behalf. In turn, the ophthalmologist and optometrist pay facility and management fees to the laser center out of the patient fees collected. While the Company believes that these arrangements do not violate any of the prohibitions in any material respects, one or more states may interpret this structure as non-compliant with the state fee-splitting prohibition, thereby requiring the Company to change its procedures in connection with billing and collecting for services. Violation of state fee-splitting prohibitions may subject the ophthalmologists and optometrists to sanctions, and may result in the Company incurring legal fees, as well as being subjected to fines or other costs, and this could have a material adverse effect on the Company’s business, financial condition and operations.

Co-management arrangements can also promote an “assembly line” mentality when it comes to LASIK procedures. By scheduling multiple procedures in the same day, these business models can maximize profits, but at what cost to the patients? It goes without saying that physicians who perform so many procedures in one day can suffer from fatigue, which can result in lack of focus or attention to detail during these complicated procedures, the end result being a botched surgery.

It is up to each patient to decide what type of care he or she wants to receive. However, remember that in LASIK, pre-operative screenings are very important. It could make the difference between you having perfect or near-perfect vision or losing your vision altogether. That may sound dramatic, but it is certainly not exaggerated. LASIK is not for everyone; a medical doctor – and not a technician must make the decision.

LASIK NEWS

Linegar v. Mark Lobanoff, M.D., and North Suburban Eye Specialists, LLP

“LASIK Debate Continues—Is LASIK Safe?”

Wymes v. Jay Lustbader, M.D.

Wymes v. Lustbader, M.D. and LASIKPlus

FDA Announces: LASIK Quality Of Life Study

Domeier v. Whitten, M.D.

New York Law Journal Online Article

Chapman v. Horsley, M.D.

Reed v. Alcon Laboratories, Inc.

News Coverage of FDA Hearing

News Coverage of LASIK

Schiffer v. Speaker

Cho v. Lee, M.D., & Mid-Manhattan Surgi-Center

Dew v. Allara

Mr. Krouner quoted in the Boston Globe

New York Times Article by Abby Ellin

Alcon LASIK Laser Recall

 

LASIK News

(1) Morris Waxler, Ph.D., was an F.D.A. insider responsible for approving the lasers used for LASIK surgery in the 1990’s. He has been in the press recently saying in effect “If I knew then what I know now,” I never would have approved LASIK.

Please click here for a link to Dr. Waxler’s interview on MSNBC on February 18, 2011.

(2) On February 16, 2011, Abby Ellin, a reporter for the New York Times, who is herself a LASIK surgery victim, published an article in salon.com “What we still don’t know about LASIK.” While reporting on the debate between Dr. Waxler and his former colleagues in the LASIK industry, she quotes LASIK patient attorney Todd J. Krouner, who says we need an honest patient satisfaction study, free of the financial bias of the LASIK industry, so that patients can make a truly informed decision whether to have eye surgery.

Please click here for a link to Abby Ellin’s article.

Todd J. Krouner represents victims of LASIK surgery throughout the United States.

For more information please contact us at info@krounerlaw.com.

xx

Linegar v. Mark Lobanoff, M.D., and North Suburban Eye Specialists, LLP

In December 2010, Layla Linegar sued Mark Lobanoff, M.D., and his practice, in connection with three eye surgeries that he performed on her in 2009. In addition to suing for medical malpractice, Ms. Linegar, who required cornea transplant surgery in January 2011, also sued for consumer fraud based on Dr. Lobanoff’s claim to be the “preferred LASIK provider” to the Minnesota Vikings.

In a February 4, 2011 article in the Minneapolis/St. Paul Business Journal, Dr. Lobanoff’s attorney was quoted, saying there is a “contractual relationship” with the Vikings. However, the Viking’s General Counsel neither confirmed any such argument, nor identified any Viking players whom Dr. Lobanoff had actually treated. For a copy of the article, “Woman blinded by surgery sues clinic over Vikings endorsement,” click here.

The plaintiffs are represented by Todd J. Krouner, from Chappaqua, New York, and Michael M. Zimmer, of M.A. Zimmer Law, from Minneapolis, Minnesota. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Zimmer has extensive experience in litigating medical malpractice actions.

For more information please contact us at info@krounerlaw.com.

Download Press Release (PDF) – December 23, 2010

Download the Complaint (PDF)

xxx””LASIK Debate Continues—Is LASIK Safe?

September 28th, 2010 – CNN LASIK Warning: “Dr. Morris Waxler, Form FDA Chief who’s group approved LASIK, tells CNN he is issuing a Public Health Advisory for the public stating “DO NOT DO LASIK, it’s DANGEROUS.”

 

Wymes v. Jay Lustbader, M.D.

Checkiem Wymes sued Dr. Jay Lustbader and LCA-Vision, Inc., doing business as LASIKPlus, for LASIK surgery performed in 2003. The complaint alleged that Mr. Wymes was diagnosed with post-LASIK ectasia in 2009, and never should have had LASIK surgery.

In response, Dr. Lustbader and LASIKPlus moved to dismiss the complaint as untimely and barred by the Maryland statute of limitations for medical malpractice.

By Memorandum Opinion dated January 7, 2011, the federal court rejected defendants’ arguments. The court held that although the surgery was performed in 2003, the injury was alleged to have been discovered in 2008, when the patient’s vision first turned blurry.

Consequently, the complaint was timely commenced within three years of discovery under Maryland law.

The decision is important for victims of LASIK malpractice in recognizing the long fuse on the time bomb of post-LASIK ectasia.

For a copy of the court’s decision, click here.

The plaintiffs are represented by Todd J. Krouner, from Chappaqua, New York, and George S, Tolley, III, of Dugan, Babij and Tolley, LLC, from Timonium, Maryland. Mr. Krouner represents victims of LASIK surgery throughout the United States. Mr. Tolley has extensive experience in litigating medical malpractice actions.

For more information please contact us at info@krounerlaw.com.

 

Chekeim Wymes and Erika Wymes v. Jay Lustbader, M.D., and LCA-Vision, Inc., d/b/a LASIKPlus

Download Press Release (PDF) – July 8, 2010

 

The FDA (Food & Drug Administration) announced that it is working with the Department of Defense and National Eye Institute to study complications arrising from LASIK surgery.

LA Times Article – “LASIK Draws FDA Attention, Warnings”

FDA Press Release – Oct. 15, 2009

 

Domeier v. Whitten, M.D., L. Edward Perraut, Jr. M.D., TLC The Laser Center (Northeast) Inc., Jo Angeles, O.D., Andrew Morgenstern, O.D., Greg W. McGrew, O.D., Paul J. Chmielewski, O.D., and Eyecare Center Of Leesburg, P.C.

Download Press Release – August 17, 2009

New York Law Journal Online Article

LASIK Eye Surgery- Litigation Challenges and Issues

Chapman v. Wilson Horsley, M.D., Horsley Eye Center, P.C., and Clear Vision Eye Center, Inc.

Download Press Release – March 18, 2009

Download the Complaint (PDF) – March 4, 2009

the Order Granting Protective Order (PDF)

Reed vs. Alcon Laboratories, Inc.

Download Press Release (PDF) – August 20, 2008

 

News Coverage of FDA Hearing

Videos: Todd Krouner speaks at the FDA LASIK hearing:

Todd Krouner FDA Hearing Materials

Todd J. Krouner was the only Plaintiff’s attorney to present at the FDA hearings on post-LASIK complications.

Todd J. Krouner’s Power Point Presentation used at the FDA hearings

Letter from Todd Krouner to the FDA regarding the April 25, 2008 hearing on post-LASIK results

News Coverage of LASIK

ABC News

ABC News Video: Hindsight 20/20: Lasik Surgery Now Unsafe? – September 22, 2010

ABC “Good Morning America”

ABC News Video of Good Morning America Exclusive: Former FDA Regulator Says LASIK Side Effects Weren’t Taken Seriously Enough – February 25, 2010

ABC News Video of Good Morning America Exclusive: Tips and Advice on LASIK From the FDA – February 25, 2010

NBC “Nightly News”

MSNBC Video of NBC Nightly News Special: FDA Takes Closer Look at LASIK Surgery

NBC “Today Show”

MSNBC Video of The Today Show Special: Is LASIK Eye Surgery Really Safe?

April 24: A decade after LASIK surgery first became available, unhappy patients like Matt Kosovolos are eager for the Food and Drug Administration to hear their grievances. NBC’s Chief Science Correspondent Robert Bazell reports.

April 25: Millions of Americans have undergone LASIK eye surgery safely, but some suffer side effects, prompting government hearings on the procedure. TODAY’s Dr. Nancy Snyderman comments.

Associated Press

April 26, 2008
In fury and despair, patients harmed by LASIK eye surgery told federal health advisers Friday of severe eye pain, blurred vision and even a son’s suicide. The advisers recommended that the government warn more clearly about the risks of the hugely popular operations.

April 28, 2008
Analysts say Advanced Medical Optics unhurt by LASIK inquiry

April 24, 2008
Lost in the hoopla of ads promising that laser vision surgery lets you toss your glasses is a stark reality: Not everyone’s a good candidate and an unlucky few do suffer life-changing side effects — lost vision, dry eye, night-vision problems.

Wall Street Journal

April 26, 2008
While past studies generally have found that 95% of LASIK patients are satisfied with their surgery, some patients have complained the surgery left them with damaged eyes and psychological problems.

April 24, 2008
Laser vision surgery has helped millions of people see better without corrective lenses. But a small number of patients have experienced troubling aftereffects from the procedure, and the Food and Drug Administration has begun taking a closer look at their complaints.

Morning Star

Morning Star – Dow Jones Wire – April 25, 2008
An FDA panel said Friday that the agency should improve its guidance on laser vision eye surgery to better inform patients of the surgery’s risks.

WebMD

WebMD – April 25, 2008
Patients Tell FDA Panel About Serious Side Effects From Corrective Eye Surgery

Schiffer v. Speaker, TLC, et al.

$7,250,000 Jury Verdict Form

Mark Schiffer’s Preoperative Corneal Topography

Textbook Topographical Depiction of Keratoconus Part 1

Textbook Topographical Depiction of Keratoconus Part 2

Mark Schiffer’s Wave Front Study Post-LASIK/Pre-Transplant

Decision Denying Summary Judgment and Granting Protective Order for Mark Schiffer’s Expert

New York Law Journal

New York Daily News

Lawyer Weekly US

Another Million Dollar Settlement for One Eye

Download Press Release (PDF) – January 11, 2008

Dew v. Allara

Former patient sues eye surgeon – The Charleston Gazette – December 7, 2007

Click here for a case summary and more info.

Download Order Granting Permission to File Damages Against Allara (PDF)

Download Amended Complaint (PDF)

Download the Surrendering of Allara’s License to the Medical Board (PDF)

Download the Surrendered License of Allara (PDF)

Click here to read the published news article.

The Charleston Gazette: City Doctor Faces Federal Drug Charges – March 25, 2008

Mr. Krouner quoted in The Boston Globe

A Second Look – The Boston Globe

New York Times Article by Abby Ellin

LASIK Surgery: When the Fine Print Applies to You

Alcon LASIK Laser Recall

Alcon LADAR6000 Laser Recalled

Alcon LASIK Laser FDA Establishment Inspection Report