The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

Regulatory Focus™ > News Articles > 2021 > 6 > CDRH qualifies new LASIK patient-reported outcomes tool

CDRH qualifies new LASIK patient-reported outcomes tool

Posted 22 June 2021 | By Kari Oakes 

CDRH qualifies new LASIK patient-reported outcomes tool

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


© 2021 Regulatory Affairs Professionals Society.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.