A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Visual acuity
研究概览
简要总结
The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25 to 45 years,
- •moderate to high myopia with astigmatism =< 2 D,
- •otherwise eye healthy,
- •CDVA of 0.8 or better (Snellen).
排除标准
- •systemic or ocular disease or previous eye surgery,
- •thin cornea,
- •a difference of more than 2 D myopia in the eyes of each subject.
研究组 & 干预措施
Carl Zeiss Meditech VisuMax laser - ReLEx flex
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
干预措施: Carl Zeiss Meditech VisuMax laser (Device)
Carl Zeiss Meditech VisuMax laser - ReLEx smile
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
干预措施: Carl Zeiss Meditech VisuMax laser (Device)
结局指标
主要结局
Visual acuity
时间窗: up to 6 months
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
次要结局
- refractive predictability(Pre-surgery, 1 week, 1 month, 3 months, 6 months)
研究者
Anders H. Vestergaard
MD, PhD student
University of Southern Denmark