NCT02396719已完成不适用
A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,541
- 试验地点
- 1
- 主要终点
- Completion rate of a round anterior capsulotomy
研究概览
简要总结
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.
详细描述
All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.
研究设计
- 研究类型
- Observational
- 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
- •Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye;
- •Must sign written informed consent;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Contraindications listed in LenSx® Laser System Operator's Manual;
- •Pregnant, nursing, or planning a pregnancy;
- •Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Completion rate of a round anterior capsulotomy
时间窗: Surgery (Day 0)
次要结局
- Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure(Surgery (Day 0))
- Completion rate of corneal incisions(Surgery (Day 0))
- Completion rate of intraocular lens (IOL) implantation(Surgery (Day 0))
- Best-corrected distance visual acuity (BCDVA)(Up to Day 30)
- Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit(Up to Day 30)
研究者
研究点 (1)
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