search
Back to results

Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prk with mitomycin vs Lasik
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring myopia, excimer laser

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease Exclusion Criteria: Diabetes, autoimmune diseases, topographic abnormalities

Sites / Locations

    Outcomes

    Primary Outcome Measures

    visual acuity
    refractive errors
    topography patterns
    aberrometry data

    Secondary Outcome Measures

    subjective evaluation

    Full Information

    First Posted
    August 15, 2006
    Last Updated
    August 15, 2006
    Sponsor
    Federal University of São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00365040
    Brief Title
    Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
    Official Title
    Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Errors
    Keywords
    myopia, excimer laser

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Prk with mitomycin vs Lasik
    Primary Outcome Measure Information:
    Title
    visual acuity
    Title
    refractive errors
    Title
    topography patterns
    Title
    aberrometry data
    Secondary Outcome Measure Information:
    Title
    subjective evaluation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease Exclusion Criteria: Diabetes, autoimmune diseases, topographic abnormalities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mauro Campos, MD
    Organizational Affiliation
    Federal University of Sao Paulo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

    We'll reach out to this number within 24 hrs