- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365040
Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
August 15, 2006 updated by: Federal University of São Paulo
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease
Exclusion Criteria:
- Diabetes, autoimmune diseases, topographic abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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visual acuity
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refractive errors
|
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topography patterns
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aberrometry data
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Secondary Outcome Measures
Outcome Measure |
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subjective evaluation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mauro Campos, MD, Federal University of São Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Completion
October 1, 2006
Study Registration Dates
First Submitted
August 15, 2006
First Submitted That Met QC Criteria
August 15, 2006
First Posted (Estimate)
August 17, 2006
Study Record Updates
Last Update Posted (Estimate)
August 17, 2006
Last Update Submitted That Met QC Criteria
August 15, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.