FDA in Brief
FDA In Brief: FDA Announces Qualification of a Medical Device Development Tool to Help Assess Patient- Reported Outcomes with LASIK Surgery
- For Immediate Release:
The following quote is attributed to William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices and Radiological Health
“LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK. The FDA has used medical device development tools to help us reach regulatory decisions and include these important patient-reported outcomes.
Patient-Reported Outcomes with LASIK Symptoms and Satisfaction—also known as PROWL-SS—has been qualified as a scientifically validated tool to assess individuals’ symptoms and satisfaction with vision associated with LASIK surgery.
This tool will support the FDA’s premarket and post-market regulatory decision making and can be used by manufacturers for the development and evaluation of LASIK devices.
PROWL-SS provides patients, eye-care providers and manufacturers with valuable information about important patient-reported outcomes.”
- Today, the U.S. Food and Drug Administration qualified the Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) through the Medical Device Development Tools (MDDT) program.
- PROWL-SS is designed to assess the presence, bother and impact of four visual symptoms (double images, glare, haloes and starbursts) and satisfaction with vision in patients undergoing LASIK surgery in support of both premarket and post-market medical device regulatory reviews.
- LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser device.
- An MDDT is scientifically validated for use in device evaluation and to support regulatory decision-making. Examples of MDDTs are clinical outcome assessments, assessments of biomarkers, and non-clinical assessment methods or models. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically plausible measurements and works as intended within the specified context of use. The use of a qualified MDDT by a product sponsor is voluntary.
- Patient-Reported Outcomes with LASIK (PROWL) is a self-administered, web-based questionnaire that was developed through the LASIK Quality of Life Collaboration Project, a partnership between the FDA, the National Eye Institute and the Department of Defense, that included two prospective, observational studies conducted from 2011-2014.
- The full PROWL questionnaire consists of up to 125 questions.
- The MDDT qualification submission for the PROWL-SS, proposed by the American Academy of Ophthalmology, includes 32 items from the full PROWL questionnaire that assess four key visual symptoms: double images, glare, halos, and starbursts, as well as an additional item to assess patient satisfaction with vision. The PROWL-SS is an instrument that can be used to assess specific patient-reported vision symptoms and satisfaction with vision after LASIK surgery.
- In addition to providing device developers with important information on clinical outcomes, the PROWL-SS, administered prior to and following LASIK surgery, can help enhance understanding of the potential risks of severe visual symptoms that can result from LASIK.
- The FDA continues to encourage patients to discuss all of the possible benefits and risks related to LASIK surgery with their health provider to help determine if they are a good candidate for this procedure.
- Health care professionals and patients should report any adverse events related to LASIK to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. The FDA monitors these reports and takes the appropriate action necessary to help ensure the safety of medical products in the marketplace.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Shirley Simson