CTRI/2022/06/043607已完成不适用
Clinical Investigation of the WaveLight® UV Femtosecond Laser for Corneal Flap Creation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Mean difference between achieved average central corneal flap thickness and intended flap thickness.
研究概览
简要总结
The WaveLight Laser demonstrated theability to accurately and safely cut corneal flaps as part of myopia correctingLASIK procedures. All flaps were successfully created and lifted and no safetyconcerns were identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex who are at least 18 years of age or older, with good ocular health, natural lens with no evidence of cataract, who meet minimum requirements for ECD, are eligible for LASIK, and have stable refraction (as determined by defined MRSE criteria) with sphere of -1.00 to -8.0 D and cylinder < 3.0 D in the study eye are eligible to participate in the study.
排除标准
- •Subjects with contraindicated systemic disease or ocular conditions, including dry eye, treatment with a contraindicated medication, or with predicted postoperative stromal bed thickness.
结局指标
主要结局
Mean difference between achieved average central corneal flap thickness and intended flap thickness.
时间窗: At 1 month
次要结局
- 1. Maximum deviation of average central flap thickness from flap thickness at the margins(2. Ease of flap lift assessed on 0-5 scale)
研究者
研究点 (3)
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