Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
详细描述
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.
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
- •Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery.
- •History of former useful form vision in worse-seeing eye
- •Acceptable ability to describe visual percepts
- •Age eighteen (18) or older
排除标准
- •History of glaucoma
- •Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage
- •Presence of communicable disease/infection
- •Pregnancy
- •History of claustrophobia
- •Inconsistent flash detection thresholds
- •Any other diseases that can effect the function of the retina
- •Subjects with a Beck Depression Inventory Interpretation score of >30 and subsequent diagnosis of depression by a psychiatrist.
- •Corneal degeneration
结局指标
主要结局
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
时间窗: From 2 weeks post-op until end of device usage, up to 10 years.
All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.
次要结局
未报告次要终点