NCT04899063已完成不适用
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery
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
- 318
- 试验地点
- 22
- 主要终点
- Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
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) undergoing cataract surgery
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
- •Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
- •Medicated IOP of <=24 mmHg
- •Unmedicated diurnal IOP of >=22 mmHg and <=34 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
Other
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 medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
时间窗: 24 Month
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%
次要结局
- Mean Change in medication-free DIOP from baseline(24 Month)
研究者
研究点 (22)
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