NCT05131087已完成不适用
A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of AEs
研究概览
简要总结
To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.
详细描述
CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22-80 years of age.
- •moderate to severe refractory glaucoma
- •Able to consent
排除标准
- •Women of child-bearing potential
- •Intraocular surgery or laser within the last 3 months
- •Ocular infection or inflammation within the last 6 months or currently active
- •Current use of anti-coagulant therapy
- •History of bleeding disorder or coagulopathies
- •Subject plans to undergo any ocular surgery (including cataract surgery) during the study period
- •History of corneal transplantation
- •History of ICE Syndrome or epithelial ingrowth/downgrowth
- •History of congenital glaucoma
- •Elevated episcleral venous pressure
- •. Persistent angle closure-
- •Previous glaucoma filtration surgery- -Presence of conjunctival scarring -
- •neovascular glaucoma
- •AC lens or scleral sutured IOL
- •inability to DC contact lenses
- •Presence of intraocular silicone oil
- •Vitreous in AC
结局指标
主要结局
Assessment of AEs
时间窗: 12 months
comparison of intra-operative and post-operative adverse events observed to events reported in published literature,
次要结局
- Change in IOP(12 months)
- Change in IOP Lowering Medications(12 months)
- Surgical Experience Evaluation(12 months)
研究者
研究点 (2)
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