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Patients testify that blurred vision, dry eyes, glare and inability to drive at night among possible effects of popular laser surgery
By Lauran Neergaard
Associated Press
Published on Saturday, Apr 26, 2008
WASHINGTON: In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe 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.
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 fewer, suffer serious, life-changing side effects: worse vision, severe dry eyes, 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 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?''
Six years of eye pain
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. . . . Patients do not want to continue to exist as helpless victims with no voice.''
The sober testimony illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad results 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.''
Clearer warnings backed
The FDA advisers — a group of mostly glasses-wearing eye doctors — recommended that the agency make the warnings it already provides for would-be Lasik patients clearer:
• 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 eyes. 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 or severe nearsightedness.
• 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 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 Lasik patients are dissatisfied. What's not clear is how many of those suffer lasting severe problems and how many just didn't get see as clearly as they had expected.
WASHINGTON: In fury and despair, patients harmed by Lasik eye surgery told federal health advisers Friday of severe 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.
Get the full article here.
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