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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 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
研究组 & 干预措施
Cadence
Experimental
Cadence procedure
干预措施: Cadence implant (Device)
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
- Surgical Experience Evaluation(12 months)
- Change in IOP(12 months)
- Change in IOP Lowering Medications(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEMIntraocular PressureOpen Angle GlaucomaNCT04700189New World Medical, Inc.42
已完成
1 期
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT02561962Amgen42
Unknown
3 期
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent ImplantationCoronary RestenosisCoronary Artery DiseaseNCT00426049German Heart Institute484
招募中
不适用
First in Human Study to Assess the Safety and the Efficacy of an Implantable Nitinol Device in the Treatment of KeratoconusKeratoconusNCT06451718Fundacio De Recerca Del Instituto De Microcirugia Ocular12
撤回
不适用
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for LasikAstigmatismMyopiaNCT00347997Bausch & Lomb Incorporated