Ten-Year Follow-up of a Blind Patient Chronically Implanted with Epiretinal Prosthesis Argus I

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• 作者：Lan Yue ; PhD¹ ; ^&lowast ; ; Paulo Falabella ; MD¹ ; ² ; ^&lowast ; ; Punita Christopher ; PhD³ ; Varalakshmi Wuyyuru ; MS³ ; Jessy Dorn ; PhD³ ; Paulo Schor ; MD ; PhD² ; Robert J. Greenberg ; MD ; PhD³ ; James D. Weiland ; PhD¹ ; Mark S. Humayun ; MD ; PhD¹ ; ^{humayun@med.usc.edu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：FDA ; Food and Drug Administration ; OCT ; optical coherence tomography ; SD ; spectral-domain ; VPU ; video processing unit
• 刊名：Ophthalmology
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：122
• 期：12
• 页码：2545-2552.e1
• 全文大小：2165 K

文摘

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 implant–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 implant–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.