Seeing a downside of laser eye surgery
April 26, 2008
Lauran Neergaard
ASSOCIATED PRESS
WASHINGTON–In fury and despair, patients harmed by Lasik eye surgery told U.S. federal health advisers yesterday of severe eye 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 per cent or fewer, suffer serious, life-changing side effects, such as worse vision, severe dry eye, glare, and 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?''
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 quite 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," Gerald 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 testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.
The FDA advisers – a group of mostly glasses-wearing eye doctors – recommended that the agency make more clear the warnings it already provides for would-be Lasik patients:
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 eye.
Some eye surgeons say 31 per cent of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5 per cent afterward.
Other studies say 48 per cent 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.
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.
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.
No one's actually considering restrictions on Lasik, but the FDA is working with eye surgeons to begin a major study next year to better understand who has bad outcomes.
In Canada, thousands of people have had corrective eye surgery, including Lasik, in the past decade.
According to the Ontario College of Physicians and Surgeons, there have been few complaints about physicians who have botched procedures or poor outcomes after such surgeries.
Health Canada regulates the safety, effectiveness and quality of medical devices used in laser eye surgery, but not the surgeries themselves.
With files from Noor Javed
Toronto Star
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