A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- ≥ 20% Reduction in Intraocular Pressure (IOP)
研究概览
简要总结
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
详细描述
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate open-angle glaucoma
- •Characteristics consistent with mild/moderate glaucoma
- •Use of one (1) to three (3) medications at time of screening exam
排除标准
- •Pigmentary or pseudoexfoliative glaucoma
- •Prior incisional glaucoma surgery
研究组 & 干预措施
iStent inject
Implantation of two GTS400 stents using G2-M-IS iStent inject
干预措施: iStent inject (Device)
Cataract surgery
Cataract surgery alone
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
≥ 20% Reduction in Intraocular Pressure (IOP)
时间窗: Baseline and Month 24
次要结局
- Diurnal IOP Reduction from Baseline(Baseline and Month 24)