A Real-World Evidence Study in China Boao Lecheng International Medical Tourism Pilot Zone of the Catalys Precision Laser System (Model: Catalys Precision Laser System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Rate of successful anterior capsulotomy
研究概览
简要总结
This study is a prospective, single-arm, observational study of the Catalys Precision Laser System in real-world clinical practice. The study will be conducted at one site at the Boao Super Hospital in Lecheng International Medical Tourism Pilot Zone of Hainan province in China. The study is being conducted to evaluate the overall performance of the Catalys Precision Laser System. One or both eyes of each subject will be included in study.
The Catalys system is used as part of cataract surgery to create LASER cuts as intended by the surgeon to aid in cataract surgery, without adversely impacting the risk to the patient.As such, the endpoints of surgeon rating of completeness of corneal incisions, anterior capsulotomy and phacofragmentation and any device related adverse events from the time of Catalys System use to 1-month postoperative follow-up should adequately cover the evaluation of the intended use of the Catalys System.
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
- 22 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
- •All criteria apply to each study eye:
- •Presence of corneal ring and/or inlay implant(s), Descemetocele with impending corneal rupture)
- •Severe corneal opacities, corneal abnormalities, significant corneal edema, or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule.
- •Any contraindications to cataract surgery
结局指标
主要结局
Rate of successful anterior capsulotomy
时间窗: Intraoperatively
If the investigator is able to remove the capsular disc from the peripheral capsule without the need of manual separation of residual tags, then it will be considered a complete capsulotomy.
Rate of successful corneal Incisions
时间窗: Intraoperatively
If the investigator is able to blunt dissect the primary incision (without the need for a secondary cutting instrument), then it will be considered a complete cut.
Rate of successful phacofragmentation as intended
时间窗: Intraoperatively
If there are no error messages or treatment interruptions occur, then phacofragmentation will be considered complete.
次要结局
未报告次要终点