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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00564213
Acronym
BQ-01-07-ARVO
Enrollment
36
Registered
2007-11-27
Start date
2005-03-31
Completion date
2007-09-30
Last updated
2008-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia

Keywords

Myopia, Mitomycin

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

Interventions

DRUGPRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds

Mitomycin 0.02%

Sponsors

Instituto de Olhos de Goiania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Myopia or compound myopic astigmatism * Stable refractive error * No associated eye disease

Exclusion criteria

* Diabetes, * Autoimmune diseases * Topographic abnormalities

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026