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NCT00365040 Clinical Trial

Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

Refractive Errors Clinical Trial

Official title:
Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00365040
Other study ID # AWMC
Secondary ID
Status Completed
Phase N/A
First received August 15, 2006
Last updated August 15, 2006
Start date December 2004
Est. completion date October 2006

Study information
Verified date July 2006
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease

Exclusion Criteria:

- Diabetes, autoimmune diseases, topographic abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Prk with mitomycin vs Lasik

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Outcome
Type Measure Description Time frame Safety issue
Primary visual acuity
Primary refractive errors
Primary topography patterns
Primary aberrometry data
Secondary subjective evaluation
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