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Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00365040
Recruitment Status : Completed
First Posted : August 17, 2006
Last Update Posted : August 17, 2006
Sponsor:
Information provided by:
Federal University of São Paulo

Brief 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

Condition or disease Intervention/treatment Phase
Refractive Errors Procedure: Prk with mitomycin vs Lasik Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
Study Start Date : December 2004
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. visual acuity
  2. refractive errors
  3. topography patterns
  4. aberrometry data

Secondary Outcome Measures :
  1. subjective evaluation


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365040


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

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ClinicalTrials.gov Identifier: NCT00365040    
Other Study ID Numbers: AWMC
First Posted: August 17, 2006    Key Record Dates
Last Update Posted: August 17, 2006
Last Verified: July 2006
Keywords provided by Federal University of São Paulo:
myopia
excimer laser
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors