Back to resultsComparison of Conventional and Custom Photorefractive Keratectomy (PRK)
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom PRK with iris registration
Conventional PRK
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 PRK
Exclusion Criteria:
- Patients desiring 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
Outcomes
Primary Outcome Measures
Visual acuity
Secondary Outcome Measures
Manifest refraction
Wavefront aberration value
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713856
Brief Title
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)
Official Title
Comparison of Conventional and Custom With Iris Registration PRK Ablations: 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
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study objective is to compare the clinical outcomes using wavefront guided PRK with iris registration and conventional laser PRK using FDA-approved laser technology on the same patient.
Detailed Description
Patients undergoing bilateral PRK on the same day will have one eye randomly assigned to custom wavefront guided PRK and the fellow eye treated with conventional PRK.
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
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Custom PRK with iris registration
Intervention Description
PRK
Intervention Type
Procedure
Intervention Name(s)
Conventional PRK
Intervention Description
PRK
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
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients deemed to be suitable candidates for bilateral PRK
Exclusion Criteria:
Patients desiring monovision correction rather than bilateral distance correction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mifflin, 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
Learn more about this trial
Comparison of Conventional and Custom Photorefractive Keratectomy (PRK)
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