A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Change in IOP of study eye between each randomized group
研究概览
简要总结
The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.
详细描述
This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.
Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.
Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated intraocular pressure (IOP)
- •Diagnosis of mild to advanced open-angle glaucoma
- •Shaffer Grade III
- •Mental capacity to cooperate when undergoing operative and postoperative examination
- •18 years of age or older
- •Provide written informed consent
- •Willing and able to return to scheduled follow-up examinations for 24-months
排除标准
- •Closed-angle and narrow-angle forms of glaucoma
- •Secondary glaucomas
- •Congenital or developmental glaucoma
研究组 & 干预措施
Hydrus Aqueous Implant
Hydrus implanted into Schlemm's Canal.
干预措施: prestudy topical glaucoma medications (Drug)
IOL placement and Hydrus implant
Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal
干预措施: prestudy topical glaucoma medications (Drug)
结局指标
主要结局
Change in IOP of study eye between each randomized group
时间窗: Baseline & One year
Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.
次要结局
- Change in glaucoma medications(Baseline & One year)