A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
研究概览
简要总结
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.
详细描述
This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.
Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.
When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.
Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Main Inclusion Criteria:
- •Diagnosis of refractory open angle glaucoma
- •Documented 21 mmHg < IOP ≤ 40 mmHg, under medication
- •Patient must provide written informed consent
排除标准
- •Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye
- •Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery
- •Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye
研究组 & 干预措施
STARflo Glaucoma Implant
Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space
干预措施: STARflo Glaucoma Implant (Device)
结局指标
主要结局
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
时间窗: 12 months
IOP of each patients at baseline will be compared to IOP of patient after 12 months
次要结局
- Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP(24 months)
- Reduction in number of IOP lowering medications at 12 months vs. baseline(12 months)
- Reduction in number of IOP lowering medications at 24 months vs. baseline(24 months)
- Rate of adverse events(24 months)
- Qualified success rate (%) at 12 months(12 months)
- Visual Acuity(12 months)
- Absolute success rate (%) at 12 months(12 months)
- Qualified success rate (%) at 24 months(24 months)
- Absolute success rate (%) at 24 months(24 months)