The U.S. Food and Drug Administration’s Ophthalmic Devices Panel convened last Friday to discuss post-LASIK surgery (laser-assisted in situ keratomileusis) quality-of-life issues. Of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA.
Approximately one in four people who seeks Lasik is not a good candidate. Perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. One young man committed suicide because of severe eye pain and fuzzy vision. Some patients have had to have corneal transplants when LASIK went wrong.
The FDA says it is concerned that doctors are not adequately informing patients about the potential risks. The FDA advisers recommended that the agency make clearer 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% of Lasik patients have some degree of dry eye before surgery, and it worsens for about 5% afterward. Other studies say 48% 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.
About 700,000 Americans a year undergo the elective laser surgery.
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.
As a result of the hearing the FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) in an attempt to compile more information on LASIK results. Because the study will take years to complete, any information given to patients considering LASIK surgery should clearly warn of the possibility of long-term vision problems.
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