NCT05696561尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 6
- 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
- •Patients who cannot be washed-out of IOP-lowering medications.
结局指标
主要结局
IOP change
时间窗: Month6
proportion of treated eyes with \> 20% change in unmedicated IOP
次要结局
- IOP meds(Month 6 and 12)
- IOP(Months 6 and 12)
研究者
研究点 (6)
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