NEW YORK : The US Food and Drug Administration (FDA) has announced it will be working with the National Eye Institute and the Department of Defence on Phase 2 of a study on the potential dangers of a surgical laser procedure known as LASIK.
It will study the scope of problems linked with laser eye-correcting surgery, such as, blurred vision and dry eyes, including determining the percentage of patients who experience negative side effects after the surgery.
The project composed of three phases saw Phase 1 begin in July, with the agency designing and implementing a Web-based questionnaire that assessed patient-reported outcomes, including evaluating the quality of life issues following the surgery.
The project expected to conclude by 2012, also includes a clinical trial for tracking patients who undergo the procedure.
Dr. Jeffrey Shuren, Acting Head of FDA's Medical Device Division says: 'This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects.'
An estimated 6-million Americans have had Lasik surgery for permanent reshaping of their corneas i. e. a clear layer covering the eye, to improve their vision. With the long-term safety of the procedure unknown, there are no guarantees of 20/20 vision, hoever, ophthalmology societies report 95% of patient satisfaction with their new vision.
Even so, a small number of patients have reported permanent eye damage following the surgery, including double vision, dry eye and halos around objects at night.
After years of complaints, the FDA in 2008 agreed to look into the problems. Last summer, according to the agency it received 140-reports of Lasik-related problems between 1998 and 2006.
Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb are some of the Lasik laser manufacturers
source:www.aaj.tv
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