NCT01603576已完成不适用
Safety and Feasibility Study of a Prototype Suprachoroidal Retinal Prosthesis for Vision Restoration
Center for Eye Research Australia4 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This study will be an initial proof of concept study, to evaluate safety and efficacy of a prototype suprachoroidal retinal implant
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
- •Aged 18 years or older
- •Either gender
- •A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia
- •Remaining visual acuity of bare light perception or less in both eyes
- •Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response
- •A history of at least 10 years of useful form vision in the worse seeing eye
- •Must be willing and able to comply with the testing and follow-up protocol demands (preferably residing within 1.5 hours of the investigational site)
排除标准
- •Optic nerve disease (history of glaucoma of more than 1 month, or history of any other optic neuropathy)
- •Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.
- •Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)
- •Any ocular condition that predisposes the subject to rubbing their eyes
- •Cognitive deficiencies, including dementia or progressive neurological disease
- •Psychiatric disorders, including depression, as diagnosed by a qualified psychologist
- •Deafness or significant hearing loss
- •Inability to speak or understand English
- •Pregnancy
- •Presence of a cochlear implant
- •Subject enrolled in another investigational drug or device trial for the treatment of their ocular condition
- •Poor general health, which would exclude them from obtaining a general anaesthetic
- •Unrealistic expectations of the bionic eye device
结局指标
主要结局
Safety
时间窗: 18 months
Number of device-related serious adverse events
次要结局
- Ability to perceive visual percepts during device stimulation(18 months)
研究者
研究点 (4)
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