NCT05501795已完成不适用
The Accuracy of Flap Thickness Versus the Pre-determined Surgical Planning Using WaveLight® FS200
Stephen Wexler1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
研究概览
简要总结
The objective is to evaluate the resultant thickness of the FS200 created LASIK flap compared to plan at the surgical visit.
详细描述
This study is a Single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral LASIK surgery. Subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The Resultant Thickness of the FS200 Created LASIK Flap Compared to Plan at the Surgical Visit.
时间窗: 1 day postoperative
次要结局
- Pre-operative Pachymetry as Measured by the EX500 Versus the Oculus Pentacam(Day 0 (surgical visit))
- The Resultant Diameter of the FS200 Created LASIK Flap Compared to Plan(1 day postoperative)
研究者
Stephen Wexler
Medical Director and Surgeon
Bismarck Lasik
研究点 (1)
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