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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

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

Page last updated: August 23, 2015

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