NCT01504282已完成不适用
Mitomycin-c Application for Photorefractive Keratectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Central corneal endothelial cell density (ECD) 6 months after the PRK
研究概览
简要总结
To evaluate the safety and efficacy of 5 seconds mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for patients with low myopia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria was ablation depth less than 65 µm,
- •a stable refractive error for at least 1 year
- •corrected distance visual acuity (CDVA) of 0.1 LogMAR or better.
排除标准
- •Patients with keratoconus suspect,
- •excessive dry eyes,
- •impaired wound healing processes,
- •lenticular changes,
- •corneal dystrophy,
- •history of ocular surgery,
- •anterior or posterior uveitis,
- •glaucoma and retinal diseases were excluded.
研究组 & 干预措施
MMC group
Active Comparator
One eye of each patient was randomly assigned to receive intraoperative topical 0.02% MMC for 5 seconds.
干预措施: mitomycin-C (Drug)
BSS group
Placebo Comparator
One eye of each patient was randomly assigned to receive balanced salt solution (BSS) with the same manner.
干预措施: Placebo (Drug)
结局指标
主要结局
Central corneal endothelial cell density (ECD) 6 months after the PRK
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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