Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds (BQ-01-07-ARVO)

Instituto de Olhos de Goiania

Status and phase: Completed; Phase 4

Conditions: High Myopia

Treatments: Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT00564213

BQ -1-07-ARVO

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Diabetes,
• Autoimmune diseases
• Topographic abnormalities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

1

Experimental group

Description:

A single intraoperative topical application of mitomycin C 0.02% for 15 seconds

Treatment:

Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds

2

Experimental group

Description:

A single intraoperative topical application of mitomycin C 0.02% for 30 seconds

Treatment:

Drug: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds