A Prospective, Multi-Center Evaluation of Corneal Flap Creation Using Cheetah Femtosecond Laser System and Cheetah Patient Interface
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Stromal Bed Surface Quality
研究概览
简要总结
The study is a prospective, open-label, comparative study design that was chosen for the purpose of optimizing the Cheetah settings, and evaluating the Cheetah system quality of LASIK flap.
详细描述
This study is a 3-month, prospective, multicenter, open-label, comparative, randomized (1:1 ratio for right and left eyes) study.
The study will be conducted at up to 5 sites and up to 300 treated subjects to achieve minimum 40 eyes with optimized settings and additional eye data for further device experience.
Both eyes of each subject will be treated. The investigator will use the Cheetah femtosecond laser, with the following possible procedures performed:
A comparison of commercial iFS femtosecond laser and PI in one eye and the Cheetah femtosecond laser (with the two piece PI) on the other eye. The eye treated with the Cheetah femtosecond laser will be the study eye and the eye treated with the commercial iFS femtosecond laser will be the control eye.
All procedures will be performed to create a LASIK flap on subjects' corneas. Flap parameters (such as flap depth, flap diameter, and hinge angle) should be the same for both eyes. The study eye will be randomized (ratio of 1:1 for right eye and left eye).
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Stromal Bed Surface Quality
时间窗: At the Operative visit, one time visit
Surface quality will be graded on a scale of 1-5 relative to Intralase iFS flap. Number of Participants with Stromal Bed Surface Quality scale of 3 or higher.
次要结局
未报告次要终点