NCT01655420

Patient Reported Outcomes With LASIK: PROWL-2

Patient-Reported Outcomes With LASIK: PROWL-2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 21 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (LASIK).

Detailed description

The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA's Center for Devices and Radiological Health (CDRH), the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK surgery. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-2 is the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a military population) will be examined psychometrically in a civilian population. PROWL-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. Additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits.

Conditions

• Laser in Situ Keratomileusis

Interventions

Type	Name	Description
PROCEDURE	LASIK	Laser eye surgery

Timeline

• Start date: 2012-07-01
• First posted: 2012-08-01
• Last updated: 2018-02-08

Locations

5 sites across 1 country: United States