NCT05696561招募中不适用
A Prospective, Multicenter, First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the DF12 CANALOPLASTY AND TRABECULOTOMY SURGICAL SYSTEM in Subjects With Open-Angle Glaucoma Undergoing Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- IOP change
研究概览
简要总结
Clinical Trial to Evaluate the Safety and Effectiveness of a Canaloplasty Device in Subjects with Open-Angle Glaucoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects qualifying for cataract surgery
- •Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 22-34 mmHg.
排除标准
- •1. Patients who cannot be washed-out of IOP-lowering medications.
研究组 & 干预措施
Treatment with a Canaloplasty Device
Other
US. FDA Approved Canaloplasty Device
干预措施: Canaloplasty Device (Device)
结局指标
主要结局
IOP change
时间窗: Month12
Reduction in unmedicated IOP
次要结局
- IOP(Month12)
- IOP meds(Month12)
研究者
研究点 (3)
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