LASIK Surgery Study to Look at Potential Quality of Life IssuesOct 20, 2009 | Parker Waichman LLP
LASIK is not for everyone.
The potential impact on quality of life from LASIK surgery is the subject of a study just launched by the Food & Drug Administration (FDA). According to an agency press release, the study is to be a collaborative effort between the National Eye Institute and the U.S. Department of Defense.
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.
Goal Of The LASIK Quality Of Life Collaboration Project.
According to the FDA, the goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems. The federally funded study will consist of three phases:
- Phase 1, which began in July 2009, is to design and implement a Web based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.
- Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.
- Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.
According to the FDA, 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.
The announcement of the LASIK study came at the same time the FDA issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.
Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.
The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use.
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