A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.
研究概览
简要总结
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
详细描述
This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
- •Operable, age-related cataract eligible for phacoemulsification.
排除标准
- •Closed Angle and narrow angle forms of Glaucoma.
- •Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.
研究组 & 干预措施
IOL placement with Hydrus Implant
Cataract extraction with intraocular lens (IOL) placement and Hydrus Implant
干预措施: Hydrus Implant (Device)
IOL placement only.
Cataract Extraction with IOL placement only.
干预措施: IOL placement (Procedure)
结局指标
主要结局
Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.
时间窗: 24 months
The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment.
次要结局
- The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.(12 months)
- Reduction in mean washed out IOP at 24 months(24 months)
- Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.(12 months)
- Diurnal IOP at 12 months following washout(12 months)