Patient Reported Outcomes With LASIK: PROWL-2
Tracking Information | |
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First Received Date ICMJE | July 30, 2012 |
Last Updated Date | July 31, 2012 |
Start Date ICMJE | July 2012 |
Primary Completion Date | |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT01655420 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Patient Reported Outcomes With LASIK: PROWL-2 |
Official Title ICMJE | Patient-Reported Outcomes With LASIK: PROWL-2 |
Brief 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. |
Study Type ICMJE | Observational |
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
Biospecimen | |
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 |
Condition ICMJE | Laser in Situ Keratomileusis |
Intervention ICMJE | Procedure: LASIK
Laser eye surgery
Other Name: Refractive surgery using LASIK for myopia, hyperopia, or astigmatism |
Study Group/Cohort (s) | LASIK
Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Intervention: Procedure: LASIK |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Recruiting |
Estimated Enrollment ICMJE | 300 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both |
Ages | 21 Years to 84 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT01655420 |
Other Study ID Numbers ICMJE | 20112124 |
Has Data Monitoring Committee | No |
Responsible Party | Food and Drug Administration (FDA) |
Study Sponsor ICMJE | Food and Drug Administration (FDA) |
Collaborators ICMJE | National Eye Institute (NEI) |
Investigators ICMJE | |
Information Provided By | Food and Drug Administration (FDA) |
Verification Date | July 2012 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |