WASHINGTON, D.C.—The Food and Drug Administration (FDA) noted this week that it has developed a valid web-based questionnaire that should “more fully capture the patient experience” with LASIK eye surgery.

FDA, in a post on its blog site, said it worked with the National Institutes of Health (NIH) and the Department of Defense (DoD) to develop the questionnaire for patients to use both before and after LASIK surgery. Drawing upon the LASIK Quality of Life Collaboration Project (LQOLCP) and the Patient-Reported Outcomes with LASIK studies (PROWL), FDA said the “new scientifically validated questions” are designed to assess patient expectations, symptoms and satisfaction. It includes definitions of the visual symptoms and images depicting the range of the symptom that should aid patients’ reporting.

Malvina Eydelman, MD, director of the FDA’s Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, is the author of the post.

The questionnaire, which is available on FDA’s website, should facilitate discussions between eyecare providers and patients considering LASIK surgery,” Eydelman noted.

The questions also can be used by ECPs to monitor symptoms before and after LASIK surgery. According to Eydelman, in the previous PROWL studies patients were “more than twice as likely to report their visual symptoms when filling out a questionnaire, than to tell them to their health care provider.”

FDA estimated that 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and “a very high number of those patients are satisfied with their surgical outcomes.” Some LASIK patients develop “unwanted visual symptoms following surgery, symptoms that can have a significant impact on their daily lives,” FDA also noted.

More information about the LASIK Quality of Life Collaboration Project is available here.