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

Sponsor
Instituto de Olhos de Goiania (Other)
Overall Status
Completed
CT.gov ID
NCT00564213
Collaborator
(none)
36
Enrollment
2
Arms
30
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date :
Mar 1, 2005
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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

Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%
Experimental: 2

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

Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Myopia or compound myopic astigmatism

    • Stable refractive error

    • No associated eye disease

    Exclusion Criteria:

    • Diabetes,

    • Autoimmune diseases

    • Topographic abnormalities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Instituto de Olhos de Goiania

    Investigators

    • Study Chair: Belquiz A Nassaralla, Instituto de Olhos de GOiânia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00564213
    Other Study ID Numbers:
    • BQ -1-07-ARVO
    First Posted:
    Nov 27, 2007
    Last Update Posted:
    Nov 26, 2008
    Last Verified:
    Nov 1, 2007
    Keywords provided by , ,
    Myopia
    Mitomycin
    Additional relevant MeSH terms:
    Myopia
    Mitomycins
    Mitomycin

    Study Results

    No Results Posted as of Nov 26, 2008