Clinical Testing of an Intracortical Visual Prosthesis System

摘要 在FDA批准的早期临床测试皮质内视觉假体的拟议工作 可行性研究同时涉及健康和生活质量问题，因为在没有任何补偿战略的情况下 在视力丧失方面，超过三分之二的盲人没有得到有报酬的工作，他们的视力下降 抑郁和社会孤立率，生活质量下降。在过去的15年里， 伊利诺伊理工学院(IIT)领导了一个基于团队的皮质内视觉假体(ICVP)项目， 由多个机构和公司组成，开发ICVP我们这个项目的切入点是： ICVP在技术上和手术上都是可行的，非人体测试已经达到了渐近极限，志愿者 参与ICVP试验有足够的可能性提供感官、知觉和心理 保证人体试验的好处，以及我们现有的ICVP团队准备进行第一个人类 临床试验。拟议的项目将使用IIT的特罗伊克博士领导的已经很成熟的项目团队。 该团队由来自七个机构的研究人员组成：伊利诺伊理工学院、伊利诺伊大学 芝加哥(加州大学)、约翰·霍普金斯大学(JHU)、德克萨斯大学达拉斯分校(UTD)、Sigics，Inc. 为生命科学(MLS)和为盲人或视障人士(CLH)设立的芝加哥灯塔。

ABSTRACT The proposed work to clinically test an intracortical visual prosthesis under an FDA-approved Early Feasibility Study addresses both health and quality-of-life issues because, without some compensatory strategy for vision loss, over two thirds of individuals with blindness are not gainfully employed, they experience higher rates of depression and social isolation, and experience a reduced quality-of-life. For the past fifteen years, The Illinois Institute of Technology (IIT) has lead a team-based IntraCortical Visual Prosthesis (ICVP) project, consisting of multiple institutions and companies, to develop the ICVP Our entry point, for this project, is: the ICVP is technically and surgically feasible, non-human testing has reached an asymptotic limitation, volunteer participation in an ICVP trial has a sufficient likelihood of providing sensory, perceptual, and psychological benefits to warrant human testing, and, that our established ICVP team is prepared to proceed to a first human clinical trial. The proposed project will use the already well-established project team lead by Dr. Troyk at IIT. This team is comprised of researchers from seven institutions: Illinois Institute of Technology, University of Chicago (UC), Johns Hopkins University (JHU), University of Texas, Dallas (UTD), Sigenics, Inc, MicroProbes for Life Science (MLS), and the Chicago Lighthouse for People who are Blind or Visually Impaired (CLH).