NCT01024803已完成不适用
Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases
Retina Implant AG12 个研究点 分布在 3 个国家目标入组 39 人开始时间: 2009年12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
- 39
- 试验地点
- 12
- 主要终点
- Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
研究概览
简要总结
Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight.
Subretinal implant "ON" results in significant visual acuity improvement, when compared to "OFF" condition.
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.
- •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 for Module-2.
排除标准
- •Period of appropriate visual functions approx. 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.
结局指标
主要结局
Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof.
时间窗: every 3 months for a period of one year
次要结局
- Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof.(every 3 months for a period of one year)
- Patient long term safety and stability of implant function(every 3 months for a period of one year)
研究者
研究点 (12)
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