NCT06809647尚未招募不适用
A Prospective Interventional Cohort Study to Evaluate the Efficacy and Safety of the AquaLumen, a Novel Filtration Procedure for the Treatment of Open Angle Glaucoma
PLU Ophthalmic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年3月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Intra Ocular pressure
研究概览
简要总结
The study will follow a group of patients with glaucoma disease that undergo a surgical procedure intended to reduce the intra-ocular pressure (IOP) for a period of one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe open angle glaucoma
- •Central corneal thickness between 480 and 610 microns
排除标准
- •surgical history of corneal graft
- •presence of corneal opacities
- •Failed prior trabeculectomy
结局指标
主要结局
Intra Ocular pressure
时间窗: 12 months
Use of concomitant topical glaucoma medications
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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