Clinical Testing of an Intracortical Visual Prosthesis System

摘要 根据FDA批准的早期临床试验， 可行性研究解决了健康和生活质量问题，因为如果没有一些补偿策略， 对于视力丧失，超过三分之二的失明者没有有报酬的工作，他们的经验更高， 抑郁症和社会孤立的发生率，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，以开发ICVP我们的切入点，对于这个项目，是： ICVP在技术上和手术上都是可行的，非人体试验已达到渐近极限，志愿者 参与ICVP试验有足够的可能性提供感官，知觉和心理 保证人体测试的好处，并且，我们建立的ICVP团队准备进行第一次人体测试。 临床试验拟议的项目将使用由IIT的Troyk博士领导的已经完善的项目团队。 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， 芝加哥（UC）、约翰霍普金斯大学（JHU）、德克萨斯大学、达拉斯（UTD）、Sigenics，Inc、MicroProbes 为生命科学（MLS），和芝加哥灯塔的人谁是盲人或视力障碍（CLH）。

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).