NCT04624698进行中（未招募）不适用
iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 358
- 试验地点
- 6
- 主要终点
- iStent inject placement and stability
研究概览
简要总结
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.
详细描述
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 22 years of age
- •Mild to moderate primary open-angle glaucoma
- •Scheduled to undergo cataract surgery
- •Able and willing to attend scheduled follow-up exams for three years postoperatively
- •Able and willing to provide written informed consent on the IRB approved Informed Consent Form
- •Operative Inclusion Criterion:
- •Successful, uncomplicated cataract surgery
排除标准
- •Angle closure glaucoma
- •Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
- •Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
结局指标
主要结局
iStent inject placement and stability
时间窗: 36 Months
The rate of clinically relevant complications associated with iStent inject placement and stability
次要结局
- Sight-threatening adverse events(36 Months)
研究者
研究点 (6)
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