Five Year Follow up of IMT-002 Patients; A Long-Term Monitoring Study of IMT-002 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 55
- 主要终点
- Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
研究概览
简要总结
This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.
详细描述
Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have participated in the IMT-002 trial.
- •Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
- •Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.
排除标准
- •Patients who have not participated in the IMT-002 trial.
结局指标
主要结局
Long term safety (Intraocular pressure, Slit lamp, Endothelial Cell Density, Visual Acuity, Complications, Adverse Events and Device Failures)
时间窗: 5 years from implantation
次要结局
未报告次要终点