A Prospective, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass System, Model iS3, in Subjects With Refractory Glaucoma
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Primary effectiveness endpoint
研究概览
简要总结
Prospective, multi-center, single-arm clinical trial to evaluate the safety and effectiveness of the Glaukos® Trabecular Micro-Bypass System Model iS3 (three stents per study eye) in subjects with refractory glaucoma.
详细描述
This is a prospective, multi-center, single arm, open-label clinical trial of the iS3 system. Up to 65 qualified subjects will be implanted with three G2-W stents in one eye and will be followed for 12 months postoperatively.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of refractory open-angle glaucoma (including pigmentary and pseudoexfoliative glaucoma) that is uncontrolled despite medical therapy and/or prior conventional incisional intraocular glaucoma surgeries.
- •Phakic or pseudophakic.
- •Males or females, 45 years of age or older.
排除标准
- •Traumatic, uveitic, neovascular, or angle-closure; or glaucoma associated with vascular disorders.
- •Active corneal inflammation or edema.
- •Retinal disorders not associated with glaucoma.
研究组 & 干预措施
Implant Group
Qualified eyes with refractory glaucoma will be implanted unilaterally with the Glaukos® Trabecular Micro-Bypass System Model iS3 (three G2-W stents per study eye), and will be followed through 12 months postoperative.
干预措施: Model iS3 three-stent trabecular micro-bypass system (Device)
结局指标
主要结局
Primary effectiveness endpoint
时间窗: Month 12 postoperative
The change in mean diurnal IOP from baseline at 12 months
次要结局
未报告次要终点