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US FDA Issues New Patient-Reported Outcome Tools For LASIK

 
• By David Filmore

The agency posted questionnaires that it says can be used to help eye-care professionals assess patients before and after LASIK surgery and can be used by device manufacturers to support product submissions.

US FDA is circulating new Web-based patient questionnaires that it says can be used to more effectively assess patient expectations and outcomes from LASIK surgery and can also be used by device manufacturers to collect patient-reported outcomes for pre-market submissions.

The PROWL pre-op and post-op questionnaires were posted to FDA's website Dec. 14. They are based on outcomes from a seven-year effort performed in conjunction with the National...

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