Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 39
- 主要终点
- Mean Change From Baseline in IOP in the Study Eyes to Month 24
研究概览
简要总结
The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of primary open angle glaucoma
- •Participants are taking at least one and no more than four topical IOP-lowering medications.
排除标准
- •Angle Closure Glaucoma
- •Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
- •Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
- •Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
研究组 & 干预措施
XEN® Gel Stent
The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
干预措施: XEN® Gel Stent (Device)
XEN® Gel Stent with Cataract Surgery
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
干预措施: Cataract Surgery (Procedure)
结局指标
主要结局
Mean Change From Baseline in IOP in the Study Eyes to Month 24
时间窗: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
时间窗: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
时间窗: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
时间窗: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
次要结局
未报告次要终点