An update on visual prosthesis.

Kailyn A Ramirez, Laura E Drew-Bear, Maria Vega-Garces, Henry Betancourt-Belandria, J Fernando Arevalo
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Abstract

Purpose: To review the available evidence on the different retinal and visual prostheses for patients with retinitis pigmentosa and new implants for other indications including dry age-related macular degeneration.

Methods: The PubMed, GoogleScholar, ScienceDirect, and ClinicalTrials databases were the main resources used to conduct the medical literature search. An extensive search was performed to identify relevant articles concerning the worldwide advances in retinal prosthesis, clinical trials, status of devices and potential future directions up to December 2022.

Results: Thirteen devices were found to be current and were ordered by stimulation location. Six have active clinical trials. Four have been discontinued, including the Alpha IMS, Alpha AMS, IRIS II, and ARGUS II which had FDA and CE mark approval. Future directions will be presented in the review.

Conclusion: This review provides an update of retinal prosthetic devices, both current and discontinued. While some devices have achieved visual perception in animals and/or humans, the main issues impeding the commercialization of these devices include: increased length of time to observe outcomes, difficulties in finding validated meaures for use in studies, unknown long-term effects, lack of funding, and a low amount of patients simultaneously diagnosed with RP lacking other comorbid conditions. The ARGUS II did get FDA and CE mark approval so it was deemed safe and also effective. However, the company became more focused on a visual cortical implant. Future efforts are headed towards more biocompatible, safe, and efficacious devices.

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视觉假体的最新进展。
目的:回顾不同的视网膜和视觉假体治疗色素性视网膜炎的现有证据,以及其他适应症的新植入物,包括干性年龄相关性黄斑变性。方法:PubMed、GoogleScholar、ScienceDirect和ClinicalTrials数据库是进行医学文献检索的主要资源。我们进行了广泛的检索,以确定截至2022年12月有关视网膜假体、临床试验、设备现状和潜在未来方向的全球进展的相关文章。结果:13个装置为电流,按刺激位置排序。其中6种正在进行临床试验。其中四种已停产,包括已获得FDA和CE标志批准的Alpha IMS、Alpha AMS、IRIS II和ARGUS II。未来的发展方向将在回顾中提出。结论:本综述提供了最新的视网膜假体装置,包括当前的和已停用的。虽然一些设备已经在动物和/或人类中实现了视觉感知,但阻碍这些设备商业化的主要问题包括:观察结果的时间延长,难以找到用于研究的有效措施,未知的长期影响,缺乏资金,以及同时诊断为RP的患者数量少,缺乏其他合共病。ARGUS II确实获得了FDA和CE的批准,因此它被认为是安全有效的。然而,该公司更专注于视觉皮质植入物。未来的努力将朝着更具生物相容性、安全性和有效性的设备迈进。
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来源期刊
CiteScore
3.50
自引率
4.30%
发文量
81
审稿时长
19 weeks
期刊介绍: International Journal of Retina and Vitreous focuses on the ophthalmic subspecialty of vitreoretinal disorders. The journal presents original articles on new approaches to diagnosis, outcomes of clinical trials, innovations in pharmacological therapy and surgical techniques, as well as basic science advances that impact clinical practice. Topical areas include, but are not limited to: -Imaging of the retina, choroid and vitreous -Innovations in optical coherence tomography (OCT) -Small-gauge vitrectomy, retinal detachment, chromovitrectomy -Electroretinography (ERG), microperimetry, other functional tests -Intraocular tumors -Retinal pharmacotherapy & drug delivery -Diabetic retinopathy & other vascular diseases -Age-related macular degeneration (AMD) & other macular entities
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