Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
Information source: Instituto de Olhos de Goiania
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Myopia
Intervention: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Instituto de Olhos de Goiania Official(s) and/or principal investigator(s): Belquiz A Nassaralla, Study Chair, Affiliation: Instituto de Olhos de GOiĆ¢nia
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Myopia or compound myopic astigmatism
- Stable refractive error
- No associated eye disease
Exclusion Criteria:
- Diabetes,
- Autoimmune diseases
- Topographic abnormalities
Locations and Contacts
Additional Information
Starting date: March 2005
Last updated: November 25, 2008
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