NCT03406416已完成不适用
Evaluation of a Suprachoroidal Retinal Prosthesis: A 44 Channel Fully Implantable Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number and severity of device related serious adverse events (SAEs)
研究概览
简要总结
This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.
详细描述
Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).
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
- •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
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 participant 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
- •Participant 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 investigational device to provide functional vision
- •Poorly controlled diabetes
- •Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained)
- •Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference
结局指标
主要结局
Number and severity of device related serious adverse events (SAEs)
时间窗: 2 years
The safety of the surgical implantation assessed by the number and severity of serious adverse events (SAEs) compared to other retinal prosthesis.
次要结局
- Efficacy - visual response(2 years)
- Quality of life - IVI - very low vision validated questionnaire(2 years)
- Visual Function and Functional Vision(2 years)
研究者
研究点 (2)
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