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FDA Panel Reviews LASIK Patient Satisfaction

On April 25, 2008 the U.S. Food and Drug Administration's Ophthalmic Devices Panel convened to discuss post-LASIK quality-of-life issues. Of the 7.6 million people who have undergone LASIK in the United States since the mid-1990s, 140 have written letters of complaint to the FDA. The FDA followed up on those complaints by holding the hearing in order to begin a review to see if new warnings about LASIK surgery are needed to alert consumers to the possibility of eye pain, dry eyes, blurred or double vision, or other problems. LASIK has enjoyed growing popularity in the United States as a result of the perception that it often results in "life changing” outcomes. In fact NASA now allows astronauts to undergo LASIK Surgery, and the U.S. military says it has been performed on 112,500 military personnel, including pilots. In 2007 a LASIK Study Task Force consisting of representatives from the Food and Drug Administration (FDA), the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the National Eye Institute was formed. The LASIK Study Task Force reviewed over 3000 clinical studies and reports on more than 16 million patients and reported a 95.4% patient satisfaction rate worldwide. The likelihood of patient dissatisfaction seems to be related to two main issues. First, some patients are simply not screened carefully enough to determine their suitability and likelihood of a satisfactory result. Individuals who have a misshapen cornea or excessively thin cornea, early cataract formation, excessively large big pupils, dry eyes for whatever reason, or underlying medical conditions such as Lupus Erythematosus or Rheumatoid Arthritis may simply not be candidates for LASIK or any type of Laser Eye Surgery to correct their vision. Nor are patients with unrealistic expectations good candidates for LASIK. Thus it is not uncommon for LASIK surgeons to reject as many as 20-30% of patients who wish to have LASIK. Second, LASIK is surgery and there are risks and complications that should be fully explained or disclosed to patients as part of the patient education process in order for them to make an informed decision. While each and every patient having LASIK is required to provide an informed consent in which all of the possible risks, complications and side effects are reviewed, it appears that even with such informed consent procedures some patients are still unaware of these possibilities. The burden of carefully educating and disclosing these potential risks to patients falls on the LASIK surgeon.

The FDA Advisory Panel listened to presentations from LASIK patients, LASIK surgeons, the United States Navy Refractive Surgery Program, researchers and other interested parties and concluded that the FDA should in fact

a) strengthen the procedures, requirements and information for providing patient education regarding risks and complications b) work with the LASIK Study Task Force to identify even better screening factors that might yet further improve patient satisfaction and outcomes.

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updated 2/27/11