Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
NCT ID: NCT00564213
Last Updated: 2008-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
36 participants
INTERVENTIONAL
2005-03-31
2007-09-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
A single intraoperative topical application of mitomycin C 0.02% for 15 seconds
PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%
2
A single intraoperative topical application of mitomycin C 0.02% for 30 seconds
PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%
Interventions
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PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds
Mitomycin 0.02%
Eligibility Criteria
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Inclusion Criteria
* Stable refractive error
* No associated eye disease
Exclusion Criteria
* Autoimmune diseases
* Topographic abnormalities
21 Years
ALL
No
Sponsors
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Instituto de Olhos de Goiania
OTHER
Principal Investigators
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Belquiz A Nassaralla
Role: STUDY_CHAIR
Instituto de Olhos de GOiânia
Other Identifiers
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BQ -1-07-ARVO
Identifier Type: -
Identifier Source: org_study_id