Patient Reported Outcomes With LASIK: PROWL-2

Food and Drug Administration (FDA)

Status: Completed

Conditions: Laser in Situ Keratomileusis

Treatments: Procedure: LASIK

Study type: Observational

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT01655420

20112124

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Investigators will be instructed to base subject eligibility on the Professional Use Information for their specific laser and keratome system, including but not limited to subjects who:
• Are aged 21 years or older.
• Have the ability to give informed consent.
• Speak and read English fluently.
• Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.
• May benefit from increased spectacle independence.
• Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.
• Have a treatment target of bilateral emmetropia. Of note, an eye must be treated within 7 days of the fellow eye.
• Express willingness and potential ability to return for all follow-up examinations through the 3-month follow-up exam under the care of the treating investigator.
• Have access to a computer with internet service.

Trial design

300 participants in 1 patient group

LASIK

Description:

Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism

Treatment:

Procedure: LASIK