NCT01497379已完成不适用
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Mono- & Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Degenerative Retinal Disease Patients.
Retina Implant AG1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Patients who are legally blind, caused by retinal degeneration of photoreceptor rods & cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones.
- •Pseudophakia
- •Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
- •Age between 18 and 78 years.
- •Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse).
- •Ability to read normal print in earlier life, optically corrected without magnifying glass.
- •Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year
排除标准
- •Period of appropriate visual functions < 12 years / lifetime.
- •Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant.
- •Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
- •Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
- •Heavy clumped pigmentation at posterior pole
- •Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
- •Amblyopia reported earlier in life on eye to be implanted
- •Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
- •Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
- •Hyperthyroidism or hypersensitivity to iodine
- •Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
- •Participation in another interventional clinical trial within the past 30 days.
研究组 & 干预措施
intra-individual implant OFF
Placebo Comparator
intra-individual implant deactivation
干预措施: surgical implantation of subretinal device (Procedure)
intra-individual implant ON
Experimental
intra-individual implant activation
干预措施: surgical implantation of subretinal device (Procedure)
结局指标
主要结局
Safety
时间窗: 1 year
treatment shows no permanent damage of function and structures that have been functional before surgery and no permanent damage to health and/or well being of patients
Efficacy
时间窗: 1 year
Activities of Daily Living \& Mobility are significantly improved with implant-ON versus OFF, as shown via tests: * Activities of Daily Living tasks or * Recognition tasks or * Mobility or * a combination of the above
次要结局
- Safety(1 year)
- Efficacy(1 year)
研究者
研究点 (1)
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