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视网膜植入物:系统评价。

Retinal implants: a systematic review.

出版信息

Br J Ophthalmol. 2014 Jul;98(7):852-6. doi: 10.1136/bjophthalmol-2013-303708.

DOI:10.1136/bjophthalmol-2013-303708
PMID:24403565
Abstract

Retinal implants present an innovative way of restoring sight in degenerative retinal diseases. Previous reviews of research progress were written by groups developing their own devices. This systematic review objectively compares selected models by examining publications describing five representative retinal prostheses: Argus II, Boston Retinal Implant Project, Epi-Ret 3, Intelligent Medical Implants (IMI) and Alpha-IMS (Retina Implant AG). Publications were analysed using three criteria for interim success: clinical availability, vision restoration potential and long-term biocompatibility. Clinical availability: Argus II is the only device with FDA approval. Argus II and Alpha-IMS have both received the European CE Marking. All others are in clinical trials, except the Boston Retinal Implant, which is in animal studies. Vision restoration: resolution theoretically correlates with electrode number. Among devices with external cameras, the Boston Retinal Implant leads with 100 electrodes, followed by Argus II with 60 electrodes and visual acuity of 20/1262. Instead of an external camera, Alpha-IMS uses a photodiode system dependent on natural eye movements and can deliver visual acuity up to 20/546. Long-term compatibility: IMI offers iterative learning; Epi-Ret 3 is a fully intraocular device; Alpha-IMS uses intraocular photosensitive elements. Merging the results of these three criteria, Alpha-IMS is the most likely to achieve long-term success decades later, beyond current clinical availability.

摘要

视网膜植入物为退行性视网膜疾病的视力恢复提供了一种创新的方法。以前的研究进展综述是由开发自己设备的小组撰写的。本系统评价通过检查描述五种代表性视网膜假体的出版物,客观地比较了选定的模型:Argus II、波士顿视网膜植入项目、Epi-Ret 3、智能医疗器械(IMI)和 Alpha-IMS(Retina Implant AG)。使用三个中期成功标准分析出版物:临床可用性、视力恢复潜力和长期生物相容性。临床可用性:Argus II 是唯一获得 FDA 批准的设备。Argus II 和 Alpha-IMS 均获得欧盟 CE 标志。其他所有产品都在临床试验中,除了波士顿视网膜植入物,它正在进行动物研究。视力恢复:分辨率理论上与电极数量相关。在具有外部摄像头的设备中,波士顿视网膜植入物以 100 个电极领先,其次是 Argus II,有 60 个电极,视力为 20/1262。而不是使用外部摄像头,Alpha-IMS 使用依赖自然眼球运动的光电二极管系统,可提供高达 20/546 的视力。长期兼容性:IMI 提供迭代学习;Epi-Ret 3 是完全眼内设备;Alpha-IMS 使用眼内光敏元件。综合这三个标准的结果,Alpha-IMS 最有可能在几十年后取得长期成功,超越当前的临床可用性。

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