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FDA Examines 'Quality of Life' for LASIK Patients
Date:4/25/2008

Panel convenes to review popular eye surgery, but complaints show it may not be for everyone

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.

"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 12.4 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 is following up on those complaints.

"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.

LASIK (laser-assisted in situ kerato
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