Interim results from the international trial of Second Sight's visual prosthesis.
Interim results from the international trial of Second Sight's visual prosthesis.
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DOI：
10.1016/j.ophtha.2011.09.028
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发表时间：
2012-04
期刊：
影响因子：
13.7
通讯作者：
Argus II Study Group
中科院分区：
文献类型：
--
作者：
Humayun MS;Dorn JD;da Cruz L;Dagnelie G;Sahel JA;Stanga PE;Cideciyan AV;Duncan JL;Eliott D;Filley E;Ho AC;Santos A;Safran AB;Arditi A;Del Priore LV;Greenberg RJ;Argus II Study Group
这项研究评估了ARGUS™II视网膜假体系统在患有严重视网膜外部变性的盲人中的作用。研究设计为单臂、前瞻性、多中心临床试验。2007年6月6日至2009年8月11日期间，有30名受试者在美国和欧洲注册。对所有受试者进行了至少6个月和最长2.7年的跟踪调查。植入物的电子刺激器和天线用硅胶环扎带缝合在巩膜上。接下来，进行平坦部玻璃体切除，通过平坦部巩膜切开术将电极阵列和电缆引入眼内。然后将微电极阵列固定在视网膜前表面。试验的主要安全终点是不良事件的数量、严重程度和关系。主要的表现终点是对视觉功能以及定向和活动任务的表现的评估。在以下任务中，启用系统的受试者比禁用系统的受试者表现得更好：物体定位(96%)；运动辨别(57%)；以及定向格栅辨别(23%)。到目前为止最好的视力记录是20/1260。当系统开启时，受试者在定向和移动任务上的平均表现明显好于关闭系统时。70%的患者没有任何严重的不良反应(SAE)。报道的最常见的SAE是眼外植入物上的结膜侵蚀或裂开，所有受试者都得到了成功的治疗，但有一例患者需要植入物而没有进一步的并发症。Second Sight的视网膜假体系统的长期安全性结果是可以接受的，大多数严重视力丧失的受试者在有系统的情况下比没有系统的人在视觉任务中表现得更好。
This study evaluates the Argus™ II Retinal Prosthesis System in blind subjects with severe outer retinal degeneration. The study design is a single arm, prospective, multicenter clinical trial. Thirty subjects were enrolled in the United States and Europe between 6 June 2007 and 11 August 2009. All subjects were followed for a minimum of six months and up to 2.7 years. The electronic stimulator and antenna of the implant was sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array was then tacked to the epiretinal surface. The primary safety endpoint for the trial was the number, severity, and relation of adverse events. Principal performance endpoints were assessments of visual function as well as performance on orientation and mobility tasks. Subjects performed statistically better with system ON vs. OFF in the following tasks: object localization (96% of subjects); motion discrimination (57%); and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects’ mean performance on Orientation and Mobility tasks was significantly better when the System was ON vs. OFF. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was successfully treated in all subjects except in one which required explantation of the device without further complications. The long-term safety results of Second Sight’s retinal prosthesis system are acceptable and the majority of subjects with profound visual loss perform better on visual tasks with system than without.
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