The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,143
- 试验地点
- 38
- 主要终点
- Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
研究概览
简要总结
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. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. 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, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
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
- Double (Participant, Outcomes Assessor)
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
- •An operable age-related cataract
- •A diagnosis of POAG treated with 1 to 4 hypotensive medications
- •Medicated IOP ≤ 31 mmHg
- •Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg
排除标准
- •Congenital or developmental glaucoma
- •Previous argon laser trabeculoplasty
- •Ab-interno or ab-externo device implanted in or through Schlemm's Canal
- •Use of oral hypotensive medication for glaucoma for treatment of fellow eye
结局指标
主要结局
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
时间窗: Baseline and 24 months
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
次要结局
- Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.(Baseline and 24 months)