Back to resultsComparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRK
SBK
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Patients deemed to be suitable candidates for bilateral LASIK surgery
Exclusion Criteria:
- Patients who desire monovision correction rather than bilateral distance correction
Sites / Locations
- University of Utah, John Moran Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
PRK
SBK
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Manifest refraction
Wavefront aberration value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00714922
Brief Title
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
Official Title
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to compare clinical outcomes from PRK and SBK using FDA-approved laser technology in the same patient
Detailed Description
Patients undergoing bilateral laser refractive surgery on the same day will be randomly assigned to have one eye treated with PRK and the fellow eye treated with SBK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
PRK
Arm Title
2
Arm Type
Active Comparator
Arm Description
SBK
Intervention Type
Procedure
Intervention Name(s)
PRK
Intervention Description
Laser refractive surgery
Intervention Type
Procedure
Intervention Name(s)
SBK
Intervention Description
Laser refractive surgery
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Manifest refraction
Time Frame
6 months
Title
Wavefront aberration value
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients deemed to be suitable candidates for bilateral LASIK surgery
Exclusion Criteria:
Patients who desire monovision correction rather than bilateral distance correction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majid Moshirfar, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah, John Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Photorefractive Keratectomy (PRK) and Sub-Bowman's Keratomileusis (SBK)
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