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FDA program tracks post-LASIK patient-reported outcomes

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CHICAGO — U.S. Food and Drug Administration studies have shown good post-LASIK visual outcomes and low complication rates, a speaker told colleagues here.

The LASIK Quality of Life Collaboration Project involves the evaluation of patient-reported outcomes (PROs) recorded on web-based and paper questionnaires, Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, said during the keynote lecture at Refractive Surgery Subspecialty Day, preceding the American Academy of Ophthalmology meeting.

Phase 1 involved a web-based instrument and interviews for measuring PROs related to quality-of-life issues. Phase 2, Patient Reported Outcomes with LASIK I (PROWL-1), was conducted at the U.S. Navy base in San Diego. Phase 3, or PROWL-2, was conducted as a national, multicenter National Eye Institute clinical study and was used to validate use of the questionnaire in the general population, Eydelman said.

“Currently, the pilot and phase 1 are completed, resulting in a web-based questionnaire with subsequent phases,” she said. “Both phase 2 and phase 3 clinical studies are completed, and analyses are currently underway.”

PROWL-1 included 262 cases and was a 6-month study, and PROWL-2 included 312 cases and was conducted at 3 months’ follow-up.

Overall, more than 95% of patients achieved binocular uncorrected visual acuity of 20/20 or better at 3 months. More than 90% of patients had monocular uncorrected visual acuity of 20/20 or better.

Four intraoperative adverse events and five postoperative adverse events were reported, she said.

The overall presence of ghosting, glare and other visual complications was lower at 3 months than before surgery. “Very and extremely bothersome symptoms" were reported in up to 4% of patients without correction at 3 months, Eydelman said.

Overall, more than 94% of patients were satisfied with visual outcomes, Eydelman said.

Disclosure: Eydelman has no relevant financial disclosures.