Evaluation of the Prophylactic Use of Mitomycin C 0.02% to Inhibit Haze Formation After Photorefractive Keratectomy for High Myopia: 15 x 30 Seconds
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopia or compound myopic astigmatism
- •Stable refractive error
- •No associated eye disease
排除标准
- •Diabetes,
- •Autoimmune diseases
- •Topographic abnormalities
研究组 & 干预措施
1
A single intraoperative topical application of mitomycin C 0.02% for 15 seconds
干预措施: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Drug)
2
A single intraoperative topical application of mitomycin C 0.02% for 30 seconds
干预措施: PRK and a single intraoperative topical application of mitomycin C 0.02% for 15 seconds (Drug)