NCT01977807Unknown4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIK
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
研究概览
简要总结
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate.
详细描述
This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithms Proscan, Zyoptix and Supracor of the 500 Hz laser system for ametropia and/or presbyopia when performed on the cornea of virgin eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
时间窗: Myopia: 6 months, Hyperopia 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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