FDA Panel Urges Stronger Warnings for LASIK Surgery

By Amanda Gardner
HealthDay Reporter
Saturday, April 26, 2008; 12:00 AM

FRIDAY, April 25 (HealthDay News) -- Golf great Tiger Woods lauds vision-correcting LASIK surgery as "life changing." NASA now allows astronauts to undergo the procedure, and the U.S. military says it has been performed on 112,500 military personnel, including pilots.

But are some of the risks and complications of this elective surgery being lost in this laudatory celebration?

The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened Friday to discuss post-LASIK quality-of-life issues. Its recommendation at day's end: That the FDA warn more clearly about the risks of the increasingly popular surgery, theAssociated Pressreported.

"This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery," said Dr. Christopher Starr, co-director of Cornea, Cataract and Refractive Surgery at New York-Presbyterian Hospital/Weill Cornell Medical College in New York City. "I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes."

According to the LASIK Study Task Force, formed in 2007, studies indicate a 95.4 percent satisfaction rate among patients worldwide. The Task Force consists of the FDA, the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the U.S. National Eye Institute.

But of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA.

Now the FDA has followed up on those complaints. Friday's hearing was part of a larger review to see if new warnings about LASIK surgery are needed to alert consumers to the possibility of eye pain, dry eyes, blurred or double vision, and other problems.

The FDA panel will also advise the full agency about how to conduct a $1.2 million study that the agency is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to determine patients' quality of life after LASIK, theWashington Postreported.

On Friday, the FDA advisers recommended that the agency make clearer the warnings regarding LASIK surgery. The recommendations include: adding photographs to illustrate what people suffering certain side effects actually see, such as the glare that can make oncoming headlights a "starburst" of light; clarifying how often patients suffer certain side effects, such as dry eye; and making clearer the conditions that should disqualify someone from LASIK, such as large pupils or severe nearsightedness, theAPreported.

"The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.

Some of those disgruntled patients were on hand for Friday's FDA hearing.

"Too many Americans have been harmed by this procedure, and it's about time this message was heard," said David Shell of Washington, D.C., who had the surgery in 1998 and said he has "not experienced a moment of crisp, good quality vision since," theAPreported.


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