NCT05999006已完成不适用
A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 7
- 主要终点
- Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
研究概览
简要总结
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)
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 mild to moderate POAG
- •Medicated IOP of <=24 mmHg
- •Shaffer angle grade of III or IV
- •CD ratio <=0.8
- •At least 45 years old
排除标准
- •Closed-angle and secondary glaucomas
- •Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
- •Cannot undergo medication washout in the study eye
- •Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
研究组 & 干预措施
ELIOS Procedure
Experimental
ELIOS Procedure
干预措施: ELIOS Procedure (Device)
结局指标
主要结局
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
时间窗: 12 Months
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications
时间窗: 12 Months
Mean Change in DIOP from baseline on the same or fewer medications
次要结局
未报告次要终点
研究者
研究点 (7)
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