Back to resultsA Comparison of PRK and LASIK for Correction of Myopia
Primary Purpose
Myopia
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
PRK
LASIK
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Excimer laser
Eligibility Criteria
Inclusion Criteria:
- spherical equivalent subjective refraction between -6.00 and -8.00 diopters
- age between 18 and 49 years
- desire for having laser refractive surgery
Exclusion Criteria:
- present or past eye disease excluding myopia
- pregnant or lactating woman
Sites / Locations
- Department of Ophthalmology, Aarhus Sygehus NBG
Outcomes
Primary Outcome Measures
Uncorrected visual acuity
Best corrected visual acuity
Best spectacle correction
Secondary Outcome Measures
IOP
Corneal thickness
Corneal wavefront aberrations
Full Information
NCT ID
NCT00404105
First Posted
November 24, 2006
Last Updated
November 24, 2006
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00404105
Brief Title
A Comparison of PRK and LASIK for Correction of Myopia
Official Title
A Prospective, Randomised Trial of Photo-Refractive Keratectomy (PRK) and Laser-in-Situ-Keratomileusis (LASIK) for Correction of Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief Summary
The study compares the precision and accuracy of two laser refractive techniques, PRK and LASIK, for correction of nearsightedness between -6 and -8 diopters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Excimer laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
PRK
Intervention Type
Procedure
Intervention Name(s)
LASIK
Primary Outcome Measure Information:
Title
Uncorrected visual acuity
Title
Best corrected visual acuity
Title
Best spectacle correction
Secondary Outcome Measure Information:
Title
IOP
Title
Corneal thickness
Title
Corneal wavefront aberrations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
spherical equivalent subjective refraction between -6.00 and -8.00 diopters
age between 18 and 49 years
desire for having laser refractive surgery
Exclusion Criteria:
present or past eye disease excluding myopia
pregnant or lactating woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Hjortdal, MD, PhD
Organizational Affiliation
Department of Ophthalmology, Aarhus Sygehus, University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Aarhus Sygehus NBG
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22879417
Citation
Ivarsen A, Hjortdal J. Seven-year changes in corneal power and aberrations after PRK or LASIK. Invest Ophthalmol Vis Sci. 2012 Sep 6;53(10):6011-6. doi: 10.1167/iovs.12-10208.
Results Reference
derived
Learn more about this trial
A Comparison of PRK and LASIK for Correction of Myopia
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