FDA initiating prospective trial of postLASIK quality of life

Planning is underway for a large national prospective study toevaluate postLASIK quality-of-life outcomes in a clinicalsetting, said Malvina B. Eydelman, MD, director, division ofophthalmic and ear, nose, and throat devices, Center for Devicesand Radiological Health (CDRH)/FDA, Rockville, MD.

The study was recommended by members of a CDRH action team. It isbeing coordinated by the Joint LASIK Study Task Force, whichcomprises representatives from the FDA, the National EyeInstitute (NEI), the American Society of Cataract and RefractiveSurgery, and the American Academy of Ophthalmology. All four ofthe organizations involved in the Joint LASIK Study Task Forcehave committed resources for conducting the trial.

The objectives of the study are to determine the level ofpostLASIK satisfaction, changes in health-related quality of lifeafter LASIK, and factors associated with the level of patientsatisfaction postLASIK.

The FDA has an integral role in the design and execution of thestudy, and it will be executed in accordance with the rulesgoverning FDA and NEI clinical trials. Consumer representationwill be included, the FDA objectively will evaluate theinformation collected, and all of the outcomes will be madepublic, Dr. Eydelman said.

"The job of the FDA is not over once a medical device isapproved," she said. "Rather, we continue to monitor deviceperformance through several different avenues with the goal ofassuring public health throughout a product's life cycle.

"The results of the prospective study will help us achieve abetter understanding of dissatisfied LASIK patients, hopefullyimprove patient selection and education, and ultimately decreasethe number of dissatisfied patients," she concluded.