NCT01841450Unknown不适用
A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 14
- 主要终点
- Rate of sight-threatening adverse events
研究概览
简要总结
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
详细描述
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •mild to moderate primary open-angle glaucoma
- •currently treated with ocular hypotensive medication
- •pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
- •subject scheduled to undergo cataract surgery
排除标准
- •primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
- •retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
研究组 & 干预措施
iStent
Experimental
Implantation of one iStent in conjunction with cataract surgery
干预措施: iStent (Device)
Cataract surgery
Active Comparator
Cataract surgery alone
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Rate of sight-threatening adverse events
时间窗: 36 months
次要结局
- Other adverse events(36 months)
研究者
研究点 (14)
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