Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
概览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nano Retina
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Safety endpoint
概览
简要总结
The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment
详细描述
The NR600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. The system is consisting of an autonomous epiretinal implant with penetrating electrodes, Glasses and a Clinician Station. The implant is Infrared (IR) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. All study subjects will be implanted with the device in one eye and will be followed for 18-months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy
- •Visual acuity in both eyes from light perception to no light perception
- •Confirmed functional ganglion cells and optic nerve in the implanted eye
- •History of useful vision
- •Mentally competent
排除标准
- •Diseases or condition that affect retinal and or optic nerve function
- •Optic Nerve diseases
- •Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning
- •Pre-disposition to eye rubbing
- •Posterior pole severe staphyloma
- •Strabismus superior to 10 prismatic diopter
- •Severe nystagmus
- •Corneal endothelium density \< 1500 cells/mm2
- •Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric
- •Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age.
结局指标
主要结局
Safety endpoint
时间窗: within 9 months post implantation
Occurrence of serious adverse events related to the device and/or to the procedure
次要结局
未报告次要终点