Lasik Eye Surgery causing problems

Patients harmed by Lasik eye surgery alternated between fury and despair Friday as they told U.S. health officials of suffering years of eye pain, blurred or double vision - even of people driven to suicide.


"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 Lasik in 1998 and says he has "not experienced a moment of crisp, good quality vision since."


Colin Dorrian was a college student when he was told he wasn't a good Lasik candidate, but went ahead anyway and later committed suicide because of the painful side-effects.


His father, Gerald, described six years of eye pain and blurred vision before reading his son's suicide note to a Food and Drug Administration panel. "I can't and won't continue facing this horror," the note said.


Matt Kotsovolos actually worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, and said doctors classified him as a success because he now has 20-20 vision - something Kotsovolos alleged is a deceptive industry practice.


"For the last two years I have suffered debilitating and unremitting eye pain," Kotsovolos said. "Patients do not want to continue to exist as helpless victims with no voice."


A decade after Lasik hit the market, the FDA is taking a new look at whether warnings about its risks are appropriate. It is also working with eye surgeons for major study to better understand who has bad outcomes and why.


The American Society for Cataract and Refractive Surgery or ASCRS claims studies show about 95 per cent of Lasik patients are satisfied with their outcome.


But not everyone's a good candidate, and an unlucky fraction do suffer life-changing side-effects: poor vision even with glasses, painful dry eyes, glare or inability to see or drive at night.


How big are the risks? The FDA agrees that about five per cent of patients are dissatisfied with Lasik. How many struggle daily with side-effects? How many are less harmed but unhappy that they couldn't completely ditch their glasses?


The range of effects on patients' quality of life is a big unknown - and the reason the FDA help a public hearing Friday as part of its new move.


"Clearly there is a group who are not satisfied and do not get the kind of results they expect," said Dr. Daniel Schultz, the FDA medical device chief. 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. 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.


Doctors advise against Lasik for one in four people who seek the surgery, said Dr. Kerry Solomon of the Medical University of South Carolina, who led a review of Lasik's safety for the ASCRS. Their pupils may be too large or corneas too thin or they may have some other condition that can increase the risk of a poor outcome.


Solomon estimates that fewer than one per cent of patients have severe complications that leave poor vision.


Other side-effects, however, are harder to pin down. 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 per cent of Lasik patients have some degree of it before the surgery and that about five per cent worsen afterward.

But dry-eye specialist Dr. Craig Fowler of the University of North Carolina says other research suggests 48 per cent 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.