NCT05548478招募中不适用
Corneal Endothelial Cell Injury Induced by Mitomycin-C in TransEpi Single Step and Alcohol Assisted Photorefractive Keratectomy PRK: A Comparative Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endothelial cell Density
研究概览
简要总结
our study will investigate the effecacy of Mitomycin-C in TransEpi single step photorefractive keratectomy (PRK) and alcohol assisted PRK
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
- 17 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Primary myopia or compound myopic astigmatism.
- •Preoperative manifest refraction spherical equivalent (MRSE) within the range of -1.0 to 8 D
- •Stable refractive error for at least 12 months before the surgery.
- •Contact lens discontinuation for at least 3 weeks.
- •Estimated corneal stromal bed thickness of more than 300mm at the thinnest point
排除标准
- •Unwilling to participate in the study.
- •Previous ocular surgery
- •Any diagnosed ocular disease
- •History of ocular trauma
研究组 & 干预措施
TransEpi single step PRK
Active Comparator
干预措施: Transepithelial PRK/MMC (Procedure)
alcohol assisted PRK
Active Comparator
干预措施: Alcohol-Assisted PRK/MMC (Procedure)
结局指标
主要结局
Endothelial cell Density
时间窗: at 3rd month
will be measured by Specular microscopy
Endothelial cell Density
时间窗: Base line
will be measured by Specular microscopy
Endothelial cell Density
时间窗: at 1st month
will be measured by Specular microscopy
次要结局
未报告次要终点
研究者
研究点 (1)
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