NCT04303897已完成不适用
A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline
研究概览
简要总结
Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy
排除标准
- •Angle closure glaucoma where angle has not been surgically opened
- •Previous glaucoma shunt/valve in the target quadrant
- •Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
- •Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
- •Active iris neovascularization or neovascularization of the iris within six months of the surgical date
- •Anterior chamber intraocular lens
- •Presence of intraocular silicone oil
- •Vitreous present in the anterior chamber
结局指标
主要结局
Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline
时间窗: Baseline to Month 12
次要结局
- Mean decrease in IOP(Baseline to Month 12)
研究者
研究点 (1)
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