FDA Takes Closer Look at Lasik Complaints

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Ten years ago Lasik eye surgery became legal in the U.S. Now, former patients are now telling their stories to federal health officials.

Most Lasik recipients do walk away with clearer vision, some even reportedly better than 20/20. But not everyone's a good candidate for the surgery. There are a misfortunate few who have suffered life-altering side effects. These problems include poor vision, painful dry eyes, as well as glare or problems seeing at night.

How big are the risks? The Food and Drug Administration believes about five percent of patients are dissatisfied with Lasik. But the range of effects on patients' quality of life is still unknown.

Public Hearing

The FDA will hold a public hearing Friday as part of a new effort to determine if warnings about Lasik's risks are appropriate. The agency is also working with eye surgeons to conduct the first major study that's expected to compile the responses from hundreds of Lasik patients. The study will help bring the focus on who has bad outcomes and exactly what their complaints are.

"Clearly there is a group who are not satisfied and do not get the kind of results they expect," FDA medical device chief Dr. Daniel Schultz said Thursday. The study should "help us predict who those patients might be before they have the procedure."

About 7.6 million Americans have undergone some form of laser vision correction, including the $2,000-per-eye Lasik. Lasik is quick and, if no problems occur, painless: Doctors cut a flap in the cornea - the clear covering of the eye- aim a laser underneath it and zap to reshape the cornea for sharper sight.

The vast majority of patients, 95 percent, see better and are happy they had Lasik, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the American Society of Cataract and Refractive Surgery.

Poor Outcome

But doctors advise against Lasik for one in four people who seek the surgery. Their pupils may be too large or corneas too thin or they may have some other condition that can heighten the risk of a poor outcome.

In Solomon's estimation, that fewer than one percent of patients have severe complications that result in poor vision. Other side effects, however, are harder to determine. Dry eye, for instance, can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form. That's the kind of question the FDA's new study is being designed to answer.

Dry eye is common even among people who never have eye surgery, and increases as people age. Solomon says that 31 percent of Lasik patients have some degree of it before the surgery and that about five percent worsen afterward.

But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 percent of patients experience some degree of dry eye at least temporarily after Lasik. Cutting the corneal flap severs nerves responsible for stimulating tear production, and how well those nerves heal in turn determines how much dry eye lingers long-term, he said.

Even if the risks are low, that's little consolation to suffering patients.

"As long as you know any ophthalmologist that's wearing glasses, don't get it done," says Steve Aptheker, 59, a Long Island lawyer who was lured by an ad for $999 Lasik.

The flaps cut in Aptheker's cornea literally became wrinkled during the surgery, blocking vision and causing severe pain. It took seven additional surgeries over four years to restore his vision, which Aptheker says still isn't quite as good as before his Lasik in 2000.

Source: The Associated Press

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