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Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00365040
First received: August 15, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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


Condition Intervention
Refractive Errors
 Procedure: Prk with mitomycin vs Lasik

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

Resource links provided by NLM:

Drug Information available for: Mitomycin
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • visual acuity
  • refractive errors
  • topography patterns
  • aberrometry data

Secondary Outcome Measures:
  • subjective evaluation

Estimated Enrollment: 40
Study Start Date: December 2004
Estimated Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes, autoimmune diseases, topographic abnormalities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365040

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Mauro Campos, MD Federal University of Sao Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00365040     History of Changes
Other Study ID Numbers: AWMC
Study First Received: August 15, 2006
Last Updated: August 15, 2006
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
myopia
excimer laser

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents

ClinicalTrials.gov processed this record on May 19, 2013