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ASCRS to participate in and co-fund study on post-lasik quality of life with US FDA
Date:4/7/2008

d factors that comprise quality of life.

The FDA deserves credit for orchestrating the Joint LASIK Study Task Force, and it has been a pleasure to work in concert with them, the National Eye Institute (NEI), and the American Academy of Ophthalmology (AAO), to develop a study that will ensure patients get the most from Americas most-popular elective procedure, said Richard L. Lindstrom, MD, co-chair of the Joint LASIK Study Task Force and immediate past president of the ASCRS. When a procedure advances as far as LASIK has, both technologically and clinically, having a greater understanding of quality of life will help both patients and doctors, and could provide the next breakthrough in the procedures performance.

Why Now

Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients. In 2006, the FDA re-evaluated symptoms and satisfaction data and reaffirmed that while the vast majority of LASIK patients were indeed satisfied with their outcomes, a few were not. In 2007, the Joint LASIK Study Task Force was formed to look into quality of life and the feasibility of a post-LASIK study. As part of this process, the FDA Ophthalmic Device Panel Medical Devices Advisory Committee will discuss post-market experience with both phakic intraocular lenses (phakic IOLs) and LASIK at its regularly scheduled April 24-25 meeting.

People undergo LASIK to improve and enhance their quality of life. The LASIK procedure was designed specifically to improve patients quality of life, and it has with great success for millions of people. What we are looking to do is study people that are satisfied with their procedure vs. people who arent even though this is a rare occasional patient. The more we can learn from that rare occasional patient, the better this procedure can be for everyone, said Dr. Solomon.

LASIK World Literature Review: Qu
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Contact: John Ciccone
jciccone@ASCRS.org
703-975-7740
EluminatePR
Source:Eurekalert

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