Ten-Year Follow-up of a Blind Patient Chronically Implanted with Epiretinal Prosthesis Argus I
Ten-Year Follow-up of a Blind Patient Chronically Implanted with Epiretinal Prosthesis Argus I
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DOI：
10.1016/j.ophtha.2015.08.008
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发表时间：
2015-12-01
期刊：
影响因子：
13.7
通讯作者：
Humayun, Mark S.
中科院分区：
文献类型：
--
作者：
Yue, Lan;Falabella, Paulo;Humayun, Mark S.
目的：Argus I植入物是美国食品药品监督管理局批准进行临床试验的第一代视网膜前膜假体。在此，我们报告了10年随访的测试结果，以研究生物电子视觉植入物在长期慢性电刺激后的生理效应。设计：病例报告。参与者：一名男性（入组研究时年龄为55岁）于2004年6月接受了Argus I手术植入，随后于2004年7月至2014年6月进行了定期检查，方法：长达十年的随访包括植入系统性能测试、受试者视功能评估和视网膜-视网膜界面分析。主要结局指标：随着时间的推移，电极阻抗和感知阈值的变化;受试者的视觉功能任务，方向和流动性测试的性能;和光学相干断层扫描数据，眼底成像，荧光素血管造影结果的评估受试者的视网膜-视网膜物理interfaces.Results：电引发光幻视存在10年后植入的视网膜前刺激器。受试者不仅能够感知光幻视，而且还可以执行视觉任务率远远高于chance.Conclusions：这十年之久的后续报告提供了进一步的支持，使用视网膜假体作为一种持久的治疗某些类型的失明。Ophthalmology 2015; 122：2545-2552（C）2015，美国眼科学会。
Purpose: The Argus I implant is the first-generation epiretinal prosthesis approved for an investigational clinical trial by the United States Food and Drug Administration. Herein we report testing results obtained from a 10-year follow-up to study the physiologic effects of the bioelectronic visual implant after prolonged chronic electrical stimulation.Design: Case report.Participant: One man, 55 years of age when enrolled in the study, underwent surgical implantation of the Argus I in June 2004, followed by periodic tests from July 2004 through June 2014, spanning a total of 10 years.Methods: The decade-long follow-up consisted of implant system performance tests, subject visual function evaluation, and implante-retina interface analysis. Main Outcome Measures: Changes in electrode impedance and perceptual threshold over the time course; subject's performance on visual function task, orientation, and mobility tests; and optical coherence tomography data, fundus imaging, and fluorescein angiography results for the assessment of subject's implante-retina physical interface.Results: Electrically elicited phosphenes were present 10 years after implantation of an epiretinal stimulator. The test subject not only was able to perceive phosphenes, but also could perform visual tasks at rates well above chance.Conclusions: This decade-long follow-up report provides further support for the use of retinal prostheses as a long-lasting treatment for some types of blindness. Ophthalmology 2015; 122:2545-2552 (C) 2015 by the American Academy of Ophthalmology.