NCT06021353已完成不适用
Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
研究概览
简要总结
The purpose of this study is to assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).
详细描述
Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good ocular health;
- •Natural lens with no evidence of cataract;
- •Eligible for LASIK;
- •Stable refraction;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Presence of dry eye;
- •Contraindicated systemic disease or ocular conditions;
- •Treatment with a contraindicated medication;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
时间窗: Month 1
Corneal flap thickness will be measured using optical coherence tomography (OCT)
次要结局
未报告次要终点
研究者
研究点 (2)
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