Manchester Vision Regeneration (MVR) Lab at Manchester Royal Eye Hospital, NIHR Manchester Clinical Research Facility and Manchester University NHS Foundation Trust, Manchester, UK.
Division Evolution & Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, University of Manchester, UK.
Eur J Ophthalmol. 2021 May;31(3):920-931. doi: 10.1177/11206721211000680. Epub 2021 Mar 18.
To date there are yet no available approved therapies for Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).
Single site, non-randomized safety and efficacy study presenting the preliminary results in a cohort of five late stage AMD (GA) patients successfully implanted with the Argus II Retinal Prosthesis System (Second Sight Medical Products Inc., Sylmar, CA, USA). Extensive fundus imaging including retinal photographs from which the GA area was measured. A combination of custom and traditional tests designed for very low vision subjects assessed visual function in study subjects. A Functional Low-Vision Observer Rated Assessment was carried out to evaluate the impact of the system on the subject's daily life. In addition, a study to evaluate structural characteristics of the visual cortex of the brain was performed in one subject using magnetic resonance imaging.
Seven device-related adverse events were reported, four of which were classed as serious adverse events. Retinal detachment was reported in three patients and was successfully treated within 12 months of onset. Testing showed an improvement in visual function in three of five patients with the system turned on. Magnetic resonance imaging assessed in one patient after implantation indicates a selective increase in cortical myelin and thickness in visual brain regions 1 year post implantation.
Epiretinal prostheses can successfully be implanted in those affected by GA secondary to late-stage AMD and can elicit visual percepts by electrical stimulation of residual neuroretinal elements and improve basic visual function in those affected.
迄今为止，尚无针对年龄相关性黄斑变性（AMD）继发的地图状萎缩（GA）的可用批准疗法。
这是一项单中心、非随机的安全性和疗效研究，在 5 名晚期 AMD（GA）患者中成功植入 Argus II 视网膜假体系统（Second Sight Medical Products Inc.，加利福尼亚州 Sylmar）的初步结果。包括视网膜照片在内的广泛眼底成像，从这些照片中测量 GA 区域。针对低视力人群设计的定制和传统测试相结合，评估研究对象的视觉功能。通过功能性低视力观察者评定来评估该系统对患者日常生活的影响。此外，对一名患者进行了一项使用磁共振成像评估大脑视觉皮层结构特征的研究。
报告了 7 起与器械相关的不良事件，其中 4 起被归类为严重不良事件。3 名患者报告了视网膜脱离，并在发病后 12 个月内成功治疗。测试显示，在开启系统的 5 名患者中的 3 名患者的视觉功能有所改善。植入后对 1 名患者进行的磁共振成像评估表明，植入后 1 年，视觉脑区的皮质髓鞘和厚度选择性增加。
视网膜假体可以成功地植入晚期 AMD 继发 GA 的患者中，并通过对残留神经视网膜元素的电刺激产生视觉感知，改善受影响患者的基本视觉功能。
