Devices

FDA has LASIK Assessment Questionnaire

FDA has partnered with the National Institutes of Health and the Department of Defense to more fully capture the patient experience with LASIK (laser-assisted in situ keratomileusis) and is using the data in a valid Web-based questionnaire that can be used to assess patients before and after surgery. CDRH director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices Malvina Eydelman says in an FDA Voice blog post that the questionnaire “can help assess patient expectations, symptoms, and satisfaction, and includes definitions of the visual symptoms and images depicting the range of the symptom to facilitate patients’ reporting. These questions can be used for a variety of purposes, such as being used by eye care providers to monitor symptoms before and after LASIK surgery. Additionally, manufacturers may wish to include such information in future LASIK product submissions along with other clinical and nonclinical evidence for FDA’s benefit-risk determination.”

The questionnaire is based on data from the LASIK Quality of Life Collaboration Project and the Patient Reported Outcomes with LASIK (PROWL) studies. Eydelman reports that less than one percent of study participants experienced difficulties performing their usual activities following LASIK surgery due to any one of the symptoms, such as starbursts, glare, ghosting, or halos, in each of the PROWL studies.

“By listening to the patient’s perspective during the development, evaluation, and use of medical devices, FDA and manufacturers can work together to better assure that LASIK devices marketed in the United States are safe, effective, and meet the needs of the patients for whom they are intended,” Eydelman concludes. “The patient’s perspective is so important to us that it is one of CDRH’s strategic priorities.”

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