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FDA Launches LASIK Study

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The Food & Drug Administration (FDA) is taking a look at quality of life issues related to LASIK surgery. According to an agency press release, LASIK Quality of Life Collaboration Project will also involve the National Eye Institute and the U.S. Department of Defense.

The study will determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.  The  results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA’s ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery. Phase 1 of the study began in July 2009.

LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye’s cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism.  LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly.  The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

LASIK is not for everyone, especially those with misshapen or excessively thin cornea, early cataract formation, big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis.  LASIK risks include lost vision, painful dry eye, glare, and night-vision problems.  Serious complications affect about one percent of the cases and FDA estimates place customer dissatisfaction at five percent.  Unfortunately, aggressive marketing campaigns often lead patients to  believe clear sight is guaranteed, even though one in four patients seeking LASIK is deemed a poor candidate.

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