Ramirez Kailyn A, Drew-Bear Laura E, Vega-Garces Maria, Betancourt-Belandria Henry, Arevalo J Fernando
Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 08901, USA.
The Wilmer Eye Institute, Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Maumenee 713, Baltimore, MD, 21287, USA.
Int J Retina Vitreous. 2023 Nov 23;9(1):73. doi: 10.1186/s40942-023-00498-1.
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.
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.
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.
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.
回顾关于视网膜色素变性患者不同视网膜和视觉假体以及用于包括干性年龄相关性黄斑变性等其他适应症的新型植入物的现有证据。
PubMed、谷歌学术、ScienceDirect和临床试验数据库是用于进行医学文献检索的主要资源。进行了广泛的检索,以识别截至2022年12月全球视网膜假体进展、临床试验、设备状况及潜在未来方向的相关文章。
发现有13种设备仍在使用,并按刺激部位排序。其中6种正在进行临床试验。4种已停产,包括已获得美国食品药品监督管理局(FDA)和欧洲合格认证(CE)的Alpha IMS、Alpha AMS、IRIS II和ARGUS II。综述中将介绍未来方向。
本综述提供了当前和已停产的视网膜假体设备的最新情况。虽然一些设备已在动物和/或人类中实现视觉感知,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测量方法、未知的长期影响、缺乏资金以及同时被诊断为视网膜色素变性且无其他合并症的患者数量较少。ARGUS II已获得FDA和CE认证,因此被认为是安全且有效的。然而,该公司后来更专注于视觉皮层植入物。未来的努力方向是研发更具生物相容性、安全性和有效性的设备。