STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- Reduction of intraocular pressure (IOP)
研究概览
简要总结
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.
详细描述
This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.
This program is designed to be an international multicenter observational study.
Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.
The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reduction of intraocular pressure (IOP)
时间窗: at 12 Months
IOP reduction compared after 12 months compared to baseline IOP
次要结局
- Occurence of Ocular Adverse Events(up to 60 Months after surgery)
- Reduction of IOP lowering medication(at 6, 12, 24, 36, 48 and 60 Months)
- Reduction of intraocular pressure (IOP) over time(at 6, 24, 36, 48 and 60 Months)