EX-PRESS® P-50 and EX-PRESS® P-200
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Percentage reduction in intraocular pressure (IOP) from baseline
研究概览
简要总结
The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term clinical performance and safety outcomes for EX-PRESS Glaucoma Filtration Devices Models P-50 and P-200.
详细描述
This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify patient charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Patients meeting the eligibility criteria who have a minimum of 5 years of follow-up data since the implantation of the P-50 or P-200 device will be enrolled, including patients whose 5-year standard of care visit is scheduled during the study enrollment period.
The overall study duration is expected to be approximately 7 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Able to understand and sign an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved informed consent form authorizing data collection prior to the review of any medical records;
- •Implanted (one eye or both) with the EXPRESS P-50 or EXPRESS P-200 device per indications for use for at least 5 years;
- •Have a minimum of 5 years of recorded follow-up data;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Enrolled in any clinical trial within the last 5 years;
- •At the time of implantation:
- •Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
- •Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
- •Diagnosed with angle-closure glaucoma.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage reduction in intraocular pressure (IOP) from baseline
时间窗: Baseline (preoperative), up to Year 5 postoperative
IOP will be measured for each eye individually using applanation tonometry and recorded in millimeters mercury (mmHG).
次要结局
未报告次要终点