NCT05159817进行中（未招募）不适用
Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ciliatech
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Assess post-op IOP reduction
研究概览
简要总结
The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.
详细描述
19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted.
These patients reached 6 months follow-up and the original study had to be interrupted.
This observational study prolonges follow-up to 36 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
排除标准
- •if cannot assist to all future follow-up visits
结局指标
主要结局
Assess post-op IOP reduction
时间窗: 12, 24 and 36 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
次要结局
未报告次要终点
研究者
研究点 (1)
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