Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.
Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.
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DOI：
10.1016/j.ophtha.2015.04.032
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发表时间：
2015-08
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：
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作者：
Ho AC;Humayun MS;Dorn JD;da Cruz L;Dagnelie G;Handa J;Barale PO;Sahel JA;Stanga PE;Hafezi F;Safran AB;Salzmann J;Santos A;Birch D;Spencer R;Cideciyan AV;de Juan E;Duncan JL;Eliott D;Fawzi A;Olmos de Koo LC;Brown GC;Haller JA;Regillo CD;Del Priore LV;Arditi A;Geruschat DR;Greenberg RJ;Argus II Study Group
视网膜色素变性是一组遗传性视网膜变性，由于光感受器丧失而导致失明。这是一种罕见的疾病，在美国影响着大约10万人。没有治愈方法，也没有批准的药物治疗来减缓或逆转RP。这项临床试验的目的是评估Argus®II视网膜假体系统(第二视觉医疗产品公司，加利福尼亚州西尔玛)在恢复因RP而完全失明的受试者方面的安全性、可靠性和益处。在此，我们报告植入后1年和3年的临床试验结果。这项研究是一项多中心、单臂、前瞻性的临床试验。在美国和欧洲的10个中心有30名受试者。受试者充当他们自己的对照--即植入的眼睛和同伴的眼睛，以及系统打开和系统关闭(本地剩余视力)。Argus II系统被植入盲人受试者的一只眼睛(通常是视力较差的眼睛)。受试者戴着安装有小型摄像头和视频处理器的眼镜，视频处理器将图像转换为刺激模式，发送到视网膜上的电极阵列。主要的结果指标是安全性(不良事件的数量、严重性和相关性)和视觉功能，通过三项基于计算机的客观测试来衡量。在30名受试者中，有29人在植入后3年仍然植入了功能正常的Argus II系统。11名受试者总共经历了23次与设备或手术相关的严重不良事件。所有人都接受了标准的眼科护理。作为一个整体，受试者在所有视觉功能测试和功能视力评估中，在打开系统的情况下表现明显好于关闭系统。Argus II试验的三年结果支持了Argus II系统对因RP而失明的患者的长期安全性和益处。这项试验的早期结果被用于获得FDA对Argus II的批准，并在欧洲获得CE标志。Argus II系统是第一个也是唯一一个同时获得两个批准的视网膜植入物。
Retinitis Pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. A rare disease, it affects about 100,000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in restoring some visual function to subjects completely blind from RP. Herein, we report clinical trial results at 1 and 3 years post-implant. The study is a multicenter, single-arm, prospective clinical trial. There were 30 subjects in 10 centers in the U.S. and Europe. Subjects served as their own controls – i.e., implanted eye vs. fellow eye, and System ON vs. System OFF (native residual vision). The Argus II System was implanted on and in a single eye (typically the worse-seeing eye) of blind subjects. Subjects wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by three computer-based, objective tests. Twenty-nine out of 30 subjects remained implanted with functioning Argus II Systems at 3 years post-implant. Eleven subjects experienced a total of 23 serious device- or surgery-related adverse events. All were treated with standard ophthalmic care. As a group, subjects performed significantly better with the System ON than OFF on all visual function tests and functional vision assessments. The three-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind from RP. Earlier results from this trial were used to gain approval of the Argus II by the FDA and a CE Mark in Europe. The Argus II System is the first and only retinal implant to have both approvals.