FDA plans to study Lasik Eye Procedures for Side Effect Data
October 17, 2009
Boston (DbTechNo) - The Food and Drug Administration (FDA) have announced their intent to perform studies into the side effects of lasik eye surgery.
The procedure is commonly advertised as a way of improving a person’s vision, but not much is actually known about its side effects.
According to the FDA, some known side effects associated with lasik eye procedures include blurry vision and dry eyes, but many more maybe present but just not known about.
Many older people choose to have the procedure done, because as we age, our vision can begin to deteriorate.
The FDA will be working closely with the National Eye Institute and the Department of Defense to determine the people at risk of side effects from the procedure and what possible side effects could be present.
“This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects,” said Dr. Jeffrey Shuren, the acting head of FDA’s medical device division.
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LASIK has a decade’s worth of peer-reviewed, worldwide clinical data - including FDA clinical trials - highlighting it’s safety and effectiveness, as well as consistent documentation of the highest patient satisfaction rate of any elective procedure (more than 95 percent). As part of the organized ophthalmic community, ASCRS remains committed to better understanding those very few patients whose expectations are not met by the procedure. The purpose of the new study is to examine LASIK’S impact on the diverse factors that comprise patient quality of life, including everything from driving, daily routine, family life, career and sports performance, to personal appearance after LASIK. The DoD’s expertise with LASIK technologies and clinical protocols solidly grounded in good science serve as a solid foundation upon which to expand the scientific body of knowledge regarding LASIK.