Patient Reported Outcomes With LASIK: PROWL-2

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier:
NCT01655420
First received: July 30, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Laser in Situ Keratomileusis
Procedure: LASIK

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-Reported Outcomes With LASIK: PROWL-2

Further study details as provided by Food and Drug Administration (FDA):

Estimated Enrollment: 300
Study Start Date: July 2012
Groups/Cohorts Assigned Interventions
LASIK
Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Procedure: LASIK
Laser eye surgery
Other Name: Refractive surgery using LASIK for myopia, hyperopia, or astigmatism

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.

  Eligibility

Ages Eligible for Study:   21 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655420

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94304
United States, Indiana
20/20 Institute
Indianapolis, Indiana, United States, 46240
United States, Kansas
Durrie Vision
Overland Park, Kansas, United States, 66211
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Food and Drug Administration (FDA)
  More Information

No publications provided

Responsible Party: Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT01655420     History of Changes
Other Study ID Numbers: 20112124
Study First Received: July 30, 2012
Last Updated: February 13, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Food and Drug Administration (FDA):
Myopia
Hyperopia
Astigmatism
Patient-reported outcomes
Patient satisfaction
Refractive Error
Emmetropia
Dry eyes
Glare
Halos
Patient expectations

ClinicalTrials.gov processed this record on September 16, 2014