Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Time to device failure
研究概览
简要总结
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.
详细描述
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS. For Germany, it is under the exceptions mentioned in §23b MPG (Medizinproduktegesetz, German Medical Device Law). Its purpose is to collect data that is created during the regular therapy with the implant. No additional examinations are performed, except a patient questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients who received a RETINA IMPLANT Alpha AMS.
- •Patients willing and able to give written informed consent.
排除标准
- 未提供
结局指标
主要结局
Time to device failure
时间窗: 6 Years
Recording of device failures
Number, nature and severity of challenges or complications during surgical procedures
时间窗: 6 Years
Recording of adverse events
Number, nature and severity of device-related adverse events and incidents until device failure or explantation
时间窗: 6 Years
Recording of adverse events
次要结局
- 1. Functional Vision Test(6 Years)
- 4. Functional Vision Tests(6 Years)
- 2. Functional Vision Test(6 Years)
- 3. Functional Vision Test(6 Years)
- Visual related quality of life (Patient reported outcome)(6 Years)