NCT00918697已完成2 期
Mechanical Versus Alcohol-Assisted Epithelial Debridement During Photorefractive Keratectomy: A Confocal Microscopic Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Corneal cellular elements.
研究概览
简要总结
In this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 D who completed all follow-up visits were evaluated.
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
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spherical equivalent ≤ -4.0 D
- •cylinder ≤ 1.50 D
排除标准
- •history of ocular trauma or surgery
- •any corneal and ocular pathologies
- •central corneal thickness < 500 µm
- •scotopic pupil diameter > 6.0 mm
- •any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders
- •the presence of systemic disorders such as collagen vascular diseases
研究组 & 干预措施
Mechanical debridment
Active Comparator
In this arm, corneal epithelium was removed during PRK using conventional mechanical method.
干预措施: Mechanical debridement (Procedure)
Alcohol-asstisted debridement
Experimental
In this arm, corneal epithelium was removed using ethanol 20% during PRK.
干预措施: Alcohol-assisted debridement (Procedure)
结局指标
主要结局
Corneal cellular elements.
Confocal microscopic findings of corneal cellular elements.
次要结局
未报告次要终点
研究者
研究点 (1)
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