A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 24
- 主要终点
- Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
研究概览
简要总结
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
详细描述
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
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, pseudoexfoliative or pigmentary glaucoma
- •IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- •Visual field mean deviation score of -3dB or worse
- •Area of healthy, free and mobile conjunctiva in the target quadrant
- •Shaffer angle grade ≥ 2 in the target quadrant
排除标准
- •Angle closure glaucoma
- •Congenital, neovascular or other secondary glaucomas
- •Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- •Previous glaucoma shunt/valve in the target quadrant
- •Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
- •History of corneal surgery, corneal opacities or corneal disease
- •Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
结局指标
主要结局
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
时间窗: 12 Months
The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
时间窗: 12 Months
The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.
次要结局
- Percentage change in mean diurnal IOP(12 months)
- Percentage change in mean diurnal IOP(12 months)