NCT04700189已完成不适用
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
研究概览
简要总结
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.
详细描述
This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.
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 must meet all the following criteria in order to be eligible for participation in this study:
- •Subjects qualifying for cataract surgery
- •Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.
排除标准
- •Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
- •Patients who could not be washed-out of IOP-lowering medications. .
结局指标
主要结局
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
时间窗: From Baseline at Month 12
Descriptive
次要结局
- Changes from baseline in number of IOP lowering medications(From Baseline at Month 12)
- Changes from baseline in intraocular pressure (IOP)(From Baseline at Month 12)
研究者
研究点 (2)
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