Back to resultsPhotorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
Primary Purpose
Hyperopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photorefractive keratectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperopia focused on measuring photorefractive keratectomy, hyperopia, radial keratotomy, refractive surgery
Eligibility Criteria
Inclusion Criteria:
- Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
- Uncorrected Visual Acuity of 20/40 or worse;
- Best-Corrected Visual Acuity of 20/60 or better.
Exclusion Criteria:
- Systemic or ocular conditions that could bias results
- Previous photorefractive surgery
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917657
Brief Title
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
Official Title
Corneal Wavefront-Guided PRK With Adjunctive Mitomycin-C for the Treatment of Hyperopia After Radial Keratotomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess the efficacy, predictability, stability and safety of corneal wavefront-guided photorefractive keratectomy (PRK) for correcting hyperopia and astigmatism after radial keratotomy (RK).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
photorefractive keratectomy, hyperopia, radial keratotomy, refractive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Photorefractive keratectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hyperopia or hyperopic astigmatism with spherical equivalent of up to + 9,25 D and astigmatism of up to - 4,5 D;
Uncorrected Visual Acuity of 20/40 or worse;
Best-Corrected Visual Acuity of 20/60 or better.
Exclusion Criteria:
Systemic or ocular conditions that could bias results
Previous photorefractive surgery
12. IPD Sharing Statement
Citations:
PubMed Identifier
20549047
Citation
Ghanem RC, Ghanem EA, Kara-Jose N. [Safety of photorefractive keratectomy with mitomycin-C for the treatment of hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Mar-Apr;73(2):165-70. doi: 10.1590/s0004-27492010000200013. Portuguese.
Results Reference
derived
PubMed Identifier
20464118
Citation
Ghanem RC, Ghanem EA, Kara-Jose N. [Corneal wavefront-guided photorefractive keratectomy with mitomycin-C for consecutive hyperopia after radial keratotomy]. Arq Bras Oftalmol. 2010 Jan-Feb;73(1):70-6. doi: 10.1590/s0004-27492010000100013. Portuguese.
Results Reference
derived
Learn more about this trial
Photorefractive Keratectomy (PRK) for Hyperopia After Radial Keratotomy
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