NCT06230393终止不适用
An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in IOP
研究概览
简要总结
The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM
详细描述
A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participated in the DF6-CL-20-01 trial.
排除标准
- •lost to follow up in the DF6-CL-20-01 trial
结局指标
主要结局
Change in IOP
时间窗: 24months; 36 months; 48months, 60 months
From Screening to annual endpoints
次要结局
- Number of IOP lowering medications(24months; 36 months; 48months, 60 months)
研究者
研究点 (1)
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