Back to resultsComparison of LASIK and SBK
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LASIK
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
LASIK
SBK
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Manifest refraction
Wavefront aberration value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00714363
Brief Title
Comparison of LASIK and SBK
Official Title
Comparison of Laser-Assisted in Situ Keratomeleusis (LASIK) vs Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 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 LASIK and SBK using FDA-approved laser technology on the same patient
Detailed Description
Patients undergoing bilateral refractive surgery on the same day will have one eye randomized to LASIK and the fellow eye assigned to SBK treatment.
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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
LASIK
Arm Title
2
Arm Type
Active Comparator
Arm Description
SBK
Intervention Type
Procedure
Intervention Name(s)
LASIK
Intervention Description
Refractive surgery
Intervention Type
Procedure
Intervention Name(s)
SBK
Intervention Description
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
84132
Country
United States
12. IPD Sharing Statement
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Comparison of LASIK and SBK
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