CDRH qualifies new LASIK patient-reported outcomes tool

Regulatory NewsRegulatory News | 22 June 2021 |  By 

A new tool to measure patient-reported outcomes (PROs) for laser-assisted in situ keratomileusis (LASIK) corrective eye surgery has been qualified by the US FDA’s Center for Devices and Radiological Health (FDA’s CDRH).
“Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK,” said William Maisel, director of the Office of Product Evaluation and Quality at CDRH. 
The newly qualified tool, Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS), looks at symptoms and vision satisfaction associated with LASIK surgery. Now that PROWL-SS is scientifically validated and has been qualified, it “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,” explained Maisel.
PROWL-SS is derived from the self-administered, web-based PROWL questionnaire, which runs to 125 questions. PROWL was developed by FDA in conjunction with the National Eye Institute on the strength of two prospective, observational studies.
PROWL-SS draws from the full PROWL battery of questions, focusing on four key visual symptoms that may be bothersome to LASIK patients after surgery. In addition to asking about double images, glare, halos and starbursts, the questionnaire also asks a single question to assess patient satisfaction with their vision. The questionnaire can be administered before and after LASIK surgery to “help enhance understanding of the potential risks of severe visual symptoms that can result from LASIK,” according to CDRH.
Qualification of the PROWL-SS by CDRH furthers the center’s goal of having developers include clinical outcome assessments (COAs) in evaluating medical devices. In addition to PROs, other COAs include clinician- and observer-reported outcomes as well as performance outcomes. ”While each COA focuses on the patient, they provide a different perspective on a patient's health status,” noted CDRH on a newly updated webpage with information and resources on using COAs in medical device decision-making.
On the webpage, CDRH provides case studies giving examples of how COAs have supported medical device submissions for devices that range from transcatheter aortic valve replacements to devices used in aesthetic procedures.
MDDT summary of evidence


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