Phase 3
N=50
Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT00663923 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Correction of Astigmatism — -0.54; -0.59 diopter — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- photorefractive keratectomy (PRK) (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tabriz University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correction of Astigmatism |
-0.54; -0.59 | <0.05 sig |
| SECONDARY Higher Order Aberrations |
0.51; 0.51 | — |
| SECONDARY Corrected Distance Visual Acuity(CDVA) |
0.02; 0.03 | — |
| SECONDARY Uncorrected Distance Visual Acuity (UCDVA) |
0.08; 0.10 | — |
| SECONDARY Surgically Induced Astigmatism |
1.98; 1.51 | — |
Summary
The purpose of this study is to determine whether cross-cylinder approach is more effective than routine method in laser correction of astigmatism.
Eligibility Criteria
Inclusion Criteria
- >20 years of age
- refractive stability for at least one year
- regular and symmetric astigmatism of >1.5 diopters
Exclusion Criteria
- corneal thickness<470 microns
- keratoconus or suspected keratoconus
- active ocular disease and systemic collagen disease
Data sourced from ClinicalTrials.gov (NCT00663923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.