A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 116
- 试验地点
- 18
- 主要终点
- Proportion of patients with serious device-related adverse event in study eye
研究概览
简要总结
The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
详细描述
The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who received a MINIject glaucoma implant within a prior clinical study
- •Patient continues to have MINIject implanted at the point of enrolment
- •Patient must provide written informed consent to participate
排除标准
- •Individuals under tutorship or trusteeship
- •Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol
结局指标
主要结局
Proportion of patients with serious device-related adverse event in study eye
时间窗: 5 years post-implantation
The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation.
次要结局
未报告次要终点