FDA LASIK Studies Delayed by 'War Efforts'
in Regulatory and Compliance
by Chris Wiltz on October 7, 2013
FDA has indefinitely delayed a study on post-operative quality of life on military personnel that have undergone LASIK surgery.
Post-operative quality-of-life studies on military personnel who have undergone LASIK eye surgeries have been delayed indefinitely due to personnel “deployments and the focus of all military staff on the war efforts,” an FDA spokeswoman
The study, known as Patient-Reported Outcomes with LASIK (PROWL-1
) and commissioned by FDA under a Department of Defense contract to be conducted at the Naval Medical Center San Diego, was announced in 2009 but mysteriously kept under wraps for a year. In October 2010, FDA issued an update estimating that enrollment would begin within three months and completion by the end of 2012.
We were told that enrollments for the final, non-military phase of the studies, known as PROWL-2, will be completed in December 2013.
Although activists for injured LASIK patients have shown skepticism about the objectivity of the studies, since Navy ophthalmology surgeons have publicly expressed enthusiasm for the controversial procedure, it is expected that they will shed light on complaints that it leads to a serious adverse reaction rate far higher than the maximum 1% on which FDA approval was based.
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