NCT04624685Unknown不适用
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 475
- 试验地点
- 24
- 主要终点
- iStent inject Placement and Stability
研究概览
简要总结
Long term follow up of subjects in the IDE study for iStent Inject to monitor safety
详细描述
To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized subject followed for 24 months in the GC-008 study
- •Able to understand study requirements
- •Willing to attend scheduled follow-up exams for 5 years post-operatively
- •Able and willing to provide written informed consent on the IRB approved Informed Consent Form
排除标准
- 未提供
结局指标
主要结局
iStent inject Placement and Stability
时间窗: 60 Months
Rate of clinically relevant complications associated with iStent inject placement and stability.
次要结局
- Sight-Threatening Adverse Events(60 Months)
研究者
研究点 (24)
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