A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- IOP reduction at 12 and 24 months on same number or fewer medications
研究概览
简要总结
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
详细描述
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.
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
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with primary open angle glaucoma (POAG)
- •Subject on two ocular hypotensive medications
排除标准
- •Traumatic, uveitic, neovascular, or angle closure glaucoma
- •Fellow eye already enrolled
研究组 & 干预措施
iStent inject surgery
Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject
干预措施: iStent inject surgery (Device)
结局指标
主要结局
IOP reduction at 12 and 24 months on same number or fewer medications
时间窗: 12 months and 24 months
IOP reduction at 12 and 24 months on same number or fewer medications
次要结局
未报告次要终点