FDA Studies Negative Effects of Lasik Eye Surgery Dec 24, 2009
Late last week the FDA announced plans to study the range of various issues surrounding and connected with laser eye corrective surgery, which included individuals suffering from blurred vision and dry eyes.
The FDA also discussed how it would work alongside the National Eye Institute as well as the Department of Defense to determine the percentage of patients who experience negative side effects following Lasik surgery. Let’s hope following this study we wont have X-men like Cyclops running around…a study that includes help from the Department of Defense…I am confused!
The initial phase of the study is currently underway with plans for an online questionnaire to help Lasik patients their quality of life following the eye correcting surgery. The project will also include clinical trials to track patients who undergo the procedure, which according to the FDA may not conclude till 2012. FDA head medical device director Dr. Jeffrey Shuren explained, “This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects.”
An estimated 6 million Americans have undergone the Lasik eye surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of perfect vision following the procedure and patients are told long-term safety of the procedure is still unknown. Several ophthalmology studies have concluded that more than 95% of patients are satisfied with their vision after the procedure. A small number of people have reported permanent damage to their eyes following the surgery including double vision, dry eyes and halos around objects at night or in the dark.
The FDA agreed to look into the problems just last year after years of complaints. The agency said that just last summer it received more than 140 reports of Lasik-related issues between 1998 and 2006. Lasik procedures have fallen off in the past year as many consumers have had to cut back on the costly surgeries, which in many cases can cost anywhere between $1,500 and $5,000.
Staff – Everythingantiaging.com
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