XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
研究概览
简要总结
A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
- •XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015
- •Exclusion Criteria
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
时间窗: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation
时间窗: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.
次要结局
- Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation(Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation)
- Change From Baseline in Mean IOP to 48 Months After Implantation(Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation)
- Percentage of Eyes Achieving Qualified Success at Month 36(Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36)
- Percentage of Eyes Achieving Qualified Success at Month 48(Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48)
- Percentage of Eyes With Adverse Events of Special Interest (AESIs)(Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months)
- Percentage of Eyes Achieving Complete Success at Month 36(Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36)
- Percentage of Eyes Achieving Complete Success at Month 48(Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48)