The Hydrus® Microstent for Intraocular Pressure (IOP) Reduction in Mild to Moderate Open-Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.
详细描述
Qualified subjects will undergo ocular hypotensive medication washout prior to implantation with the Hydrus Microstent. Following implantation on Day 0, subjects will attend 8 scheduled postoperative visits: Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.
A decision to terminate the study was made by the Sponsor arising from challenges with enrollment of the target study population, leading to suspension of enrollment and revision of the follow-up period to 12 months. The total duration of participation for each subject was approximately 13 months including the medication washout prior to implantation.
This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Early or moderate glaucomatous optic nerve damage;
- •Uncomplicated cataract surgery with well centered posterior chamber IOL greater than or equal to 365 days prior to the screening visit;
- •Inadequately controlled IOP;
- •Shaffer angle grade III-IV in all four quadrants;
- •Age appropriate minimum central endothelial cell density;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma;
- •Requires oral hypotensive medications;
- •Shallow or flat anterior chamber;
- •Prior glaucoma surgery;
- •Ocular hypertension;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Hydrus Microstent
Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.
干预措施: Hydrus Microstent (Device)
Hydrus Microstent
Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.
干预措施: Ophthalmic surgery (Procedure)
结局指标
主要结局
Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception
时间窗: Baseline, Month 12 postoperative
Intraocular pressure (IOP) will be measured using Goldmann tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure (DIOP). Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. This is a co-primary endpoint. No hypothesis testing is prespecified.
次要结局
- Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception(Baseline, Month 12 postoperative)