Months went by with no word from the FDA on the proposed study. LASIK patient advocates accused the FDA of stalling while hundreds of reports of LASIK-related adverse events poured in to the agency. Apparently, the FDA had quietly scrapped plans for involving organized ophthalmology in the proposed study.
Read more...October 2010 Archives
A year after announcing a study to determine the percentage of LASIK laser vision-correction patients with significant quality of life problems after having the surgery and to identify predictors of these problems, FDA 10/19 provided an update on its plans for the three-part study that will run until the end of 2012. Details of the study have been kept under wraps, with numerous requests for information practically being ignored by the agency.
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