The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 20
- 主要终点
- Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
详细描述
Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.
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
- •Open-angle glaucoma with optic nerve pathology;
- •BCVA of 20/80 or better in study eye;
- •Refractory glaucoma;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;
- •Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;
- •Pre-perimetric glaucoma;
- •Ocular hypertension
- •Shallow or flat anterior chamber;
- •Other protocol-specified 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
Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline
时间窗: Baseline, Month 12
Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.
次要结局
- Mean Change From Baseline in MDIOP at Month 12(Baseline, Month 12)