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Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds (BQ-01-07-ARVO)

Primary Purpose

High Myopia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Myopia focused on measuring Myopia, Mitomycin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    A single intraoperative topical application of mitomycin C 0.02% for 15 seconds

    A single intraoperative topical application of mitomycin C 0.02% for 30 seconds

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 26, 2007
    Last Updated
    November 25, 2008
    Sponsor
    Instituto de Olhos de Goiania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00564213
    Brief Title
    Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
    Acronym
    BQ-01-07-ARVO
    Official Title
    Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Instituto de Olhos de Goiania

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate and compare the effect of the prophylactic use of two different exposure times of mitomycin C (MMC) 0.02% to inhibit haze formation after photorefractive keratectomy (PRK) for high myopia (> -7.0 D). Methods: Forty six eyes of twenty three patients, 8 men and 15 women, with high myopia were included in this prospective study. Mean age at the time of PRK plus MMC was 31.7 years. Before PRK, the mean spherical equivalent was -8.50 D (range, -7.25 to -10.50 D). In each patient, one eye was randomly assigned to PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Group 1) and the fellow eye, for 30 seconds (Group 2).The inclusion criteria were high myopia, no central corneal opacity and inadequate corneal thickness to allow a safe Laser in situ keratomileusis procedure. Refraction, uncorrected visual acuity, best spectacle-corrected visual acuity (BSCVA), and slit-lamp evidence of corneal opacity (haze) were evaluated over 12 months

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Myopia
    Keywords
    Myopia, Mitomycin

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    A single intraoperative topical application of mitomycin C 0.02% for 15 seconds
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    A single intraoperative topical application of mitomycin C 0.02% for 30 seconds
    Intervention Type
    Drug
    Intervention Name(s)
    PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
    Intervention Description
    Mitomycin 0.02%

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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
    Belquiz A Nassaralla
    Organizational Affiliation
    Instituto de Olhos de GOiânia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds

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