Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.
Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.
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DOI：
10.1016/j.ophtha.2016.06.049
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发表时间：
2016-10
期刊：
影响因子：
13.7
通讯作者：
Greenberg, Robert J.
中科院分区：
文献类型：
--
作者：
da Cruz, Lyndon;Dorn, Jessy D.;Humayun, Mark S.;Dagnelie, Gislin;Handa, James;Barale, Pierre-Olivier;Sahel, Jose-Alain;Stanga, Paulo E.;Hafezi, Farhad;Safran, Avinoam B.;Salzmann, Joel;Santos, Arturo;Birch, David;Spencer, Rand;Cideciyan, Artur V.;de Juan, Eugene;Duncan, Jacque L.;Eliott, Dean;Fawzi, Amani;de Koo, Lisa C. Olmos;Ho, Allen C.;Brown, Gary;Haller, Julia;Regillo, Carl;Del Priore, Lucian V.;Arditi, Aries;Greenberg, Robert J.
Argus®II视网膜假体系统(Second Sight Medical Products，Inc.，Sylmar，CA)旨在为因视网膜色素变性(RP)或视网膜外变性而失明的患者恢复部分视力。2006年启动了一项临床试验，研究Argus II系统在因终末期RP而导致裸露或没有光感的患者中的长期安全性和有效性。这项研究是一项前瞻性、多中心、单臂临床试验。患者内部对照包括未植入的对侧眼和患者使用该系统时的天然剩余视力与他们的视力的比较。在美国和欧洲的10个中心有30名受试者。对视力较差的盲人植入Argus II系统。患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。次要测量包括在客观评分的现实世界任务中的功能视觉表现。在植入后5年，30名患者中仍有24名植入了功能正常的Argus II系统。从3年的时间点开始，只有一次额外的严重不良事件发生。在所有视觉功能测试和功能视觉任务中，患者在打开系统的情况下表现明显好于关闭系统。Argus II试验的五年结果支持了Argus II系统对因RP而失明的患者的长期安全性和益处。Argus II是第一个也是唯一一个在欧洲经济区、美国和加拿大获得市场批准的视网膜植入物。
The Argus® II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) was developed to restore some vision to patients blind from retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception due to end-stage RP. The study is a prospective, multicenter, single-arm, clinical trial. Within-patient controls included the non-implanted fellow eye and patients' native residual vision compared to their vision when using the System. There were 30 subjects in 10 centers in the U.S. and Europe. The worse-seeing eye of blind patients was implanted with the Argus II System. Patients 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. Secondary measures included functional vision performance on objectively-scored real-world tasks. Twenty-four out of 30 patients remained implanted with functioning Argus II Systems at 5 years post-implant. Only one additional serious adverse event was experienced since the 3-year time point. Patients performed significantly better with the System ON than OFF on all visual function tests and functional vision tasks. The five-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. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
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影响因子：
1.9
作者：
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影响因子：
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DOI：
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发表时间：
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期刊：
Clinical ophthalmology (Auckland, N.Z.)
影响因子：
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作者：
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影响因子：
13.7
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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
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影响因子：
3.7
作者：
Ayton LN;Blamey PJ;Guymer RH;Luu CD;Nayagam DA;Sinclair NC;Shivdasani MN;Yeoh J;McCombe MF;Briggs RJ;Opie NL;Villalobos J;Dimitrov PN;Varsamidis M;Petoe MA;McCarthy CD;Walker JG;Barnes N;Burkitt AN;Williams CE;Shepherd RK;Allen PJ;Bionic Vision Australia Research Consortium
通讯作者：
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