A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 58
- 主要终点
- Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
研究概览
简要总结
Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.
详细描述
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.
Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg -
排除标准
- •Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
结局指标
主要结局
Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure
时间窗: 12 months
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 12 months follow-up
Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure
时间窗: 24 months
The primary effectiveness outcome is ≥ 20% reduction in mean diurnal IOP without increasing number of glaucoma medications from baseline to 24 months follow-up
次要结局
- Mean Diurnal Intraocular Pressure Change(24 months)
- Number of Participants With Postoperative Interventions at 12 Months(12 months)
- Participants With Postoperative Interventions at 24 Months(24 months)