NCT01526291

Patient-Reported Outcomes With LASIK:PROWL-1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 21 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates a questionnaire designed to measure satisfaction and ophthalmic-related quality of life (QOL)in up to 550 active duty subjects prior to and six 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, the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK. 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-1 is the second phase of the larger LQOLCP project. This prospective, questionnaire-based study will be conducted by the Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) and the National Eye Institute (NEI). The primary purpose of this study is to explore the psychometric properties of a newly developed questionnaire assessing satisfaction and ophthalmic-related quality of life (QOL) in 550 active duty patients over a period of six months prior to and following state-of-the-art laser in situ keratomileusis (LASIK). Specific topics of interest include: functional limitations, dry eye symptoms, pre-operative expectations, depression, anxiety, post-operative symptoms, dispositional optimism, and satisfaction. Additionally, standard-of-care, non-invasive clinical data will be collected pre- and postoperatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, corneal topography, and other clinical assessments), and analyzed. The questionnaire in this study is a newly developed instrument which, once psychometrically evaluated in this U.S. Navy/FDA/NEI collaboration, will be used in future large-scale, multicenter FDA clinical studies that include civilian refractive surgery centers throughout the United States.

Conditions

• Laser in Situ Keratomileusis

Timeline

• Start date: 2011-08-01
• First posted: 2012-02-03
• Last updated: 2018-02-08

Locations

1 site across 1 country: United States