NCT01401088Unknown4 期
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
适应症
试验速览
- 阶段
- 4 期
- 发起方
- Aurolab
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intra Ocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.
详细描述
Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.
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
- •18 years of age or older
- •Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
- •Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
- •Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
- •IOP≥18 mm of Hg with or without anti glaucoma medications
- •If taking glaucoma medications, stable dose for 6 weeks
排除标准
- •Age<18 years
- •Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
- •Corneal abnormalities that would preclude accurate IOP readings
- •Uncontrolled systemic diseases
- •Endothelial cell count<1800cells/mm
- •Any other active ocular disease,(active uveitis, ocular infection)
结局指标
主要结局
Intra Ocular Pressure (IOP)
时间窗: One year
Mean Intraocular pressure (IOP) reduction from pre operative IOP
次要结局
- Success rate(one year)
- Number of patients with adverse events as a measure of safety(one year)
研究者
研究点 (2)
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