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

Phase 4

Completed

• Conditions: High Myopia
• Interventions: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds

• Registration Number: NCT00564213
• Lead Sponsor: Instituto de Olhos de Goiania

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study Completion: 2007-09
• Status Verified: 2007-11
• Study First Submitted: 2007-11-26
• Study First Submitted QC: 2007-11-26
• Study First Posted: 2007-11-27
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

• Diabetes,
• Autoimmune diseases
• Topographic abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds	A single intraoperative topical application of mitomycin C 0.02% for 15 seconds
2	PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds	A single intraoperative topical application of mitomycin C 0.02% for 30 seconds