Patient Reported Outcomes With LASIK: PROWL-2
PROWL-2
Patient-Reported Outcomes With LASIK: PROWL-2
1 other identifier
observational
300
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 30, 2012
CompletedFirst Posted
Study publicly available on registry
August 1, 2012
CompletedFebruary 8, 2018
February 1, 2018
July 30, 2012
February 6, 2018
Conditions
Keywords
Study Arms (1)
LASIK
Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
Interventions
Laser eye surgery
Eligibility Criteria
Individuals age of 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Food and Drug Administration (FDA)lead
- National Eye Institute (NEI)collaborator
Study Sites (5)
Stanford University School of Medicine
Stanford, California, 94304, United States
20/20 Institute
Indianapolis, Indiana, 46240, United States
Durrie Vision
Overland Park, Kansas, 66211, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57105, United States
Related Publications (2)
Eydelman M, Hilmantel G, Tarver ME, Hofmeister EM, May J, Hammel K, Hays RD, Ferris F 3rd. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies. JAMA Ophthalmol. 2017 Jan 1;135(1):13-22. doi: 10.1001/jamaophthalmol.2016.4587.
PMID: 27893066RESULTHays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.
PMID: 27893063RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2012
First Posted
August 1, 2012
Study Start
July 1, 2012
Last Updated
February 8, 2018
Record last verified: 2018-02