NCT06246136招募中不适用
A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 21
- 主要终点
- PRIMARY EFFECTIVENESS ENDPOINTS : IOP
研究概览
简要总结
The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects.
- •40 years old or older.
- •Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
- •Visually significant cataract eligible for phacoemulsification.
排除标准
- •All forms of angle closure glaucoma
- •Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
- •Congenital or developmental glaucoma
- •Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit
研究组 & 干预措施
Arm 1
Active Comparator
ELIOS
干预措施: ELIOS (Procedure)
Arm 2
Active Comparator
Competitor Device
干预措施: Competitor Device (Procedure)
结局指标
主要结局
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
时间窗: 12 months
Mean change in post-washout diurnal IOP from baseline to 12 months.
次要结局
- SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP(12 months)
- SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP(24 months)
- SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications(12 months)
- SECONDARY EFFECTIVENESS ENDPOINTS : Medications(12 months)
研究者
研究点 (21)
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