FDA to study quality of life problems associated with Lasik surgery

The AP that "the Food and Drug Administration announced plans Thursday to study the scope of problems connected with laser eye-correcting surgery, which include blurred vision and dry eyes." The agency "says it will work with the National Eye Institute and the Department of Defense to determine the percentage of patients who experience negative side effects following" Lasik (laser-assisted in situ keratomileusis) surgery. Dr. Jeffrey Shuren, the acting head of FDA's medical device division, said, "This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects."

Bloomberg News that "the first phase of the study began in July and involves online questionnaires." According to Bloomberg, "pressure from patients dissatisfied with laser eye surgery prodded US regulators to begin a study of the procedure's effects and warn Lasik centers to better track complications, an advocate said." The agency said Thursday "that recent inspections showed 17 undisclosed Lasik centers had inadequate systems for reporting adverse effects of the surgery."

Although "Lasik has many ardent admirers among the more than 12 million in the US who have had it, between 2% and 5% of patients getting the surgery -- as many as 75,000 per year -- are thought to have lasting post-operative problems that range from painful dry-eye to poorer vision, halos, glare and even blindness," the Los Angeles Times "Booster Shots" blog reports. "The FDA calls these 'quality of life' problems following the laser surgery, and has acknowledged that it has recorded no more than a small fraction of such problems during the Lasik industry's period of explosive growth." CQ Today and the UK's Press Association also cover the story. Reuters, meanwhile, reports on the FDA's warning to Lasik centers.

Posted in: Health, Lasik, Medical Specialties, Medicine, National Eye Institute, Ophthalmology