Development and Testing of Low Vision Assessment Tools for Retinal Prostheses.

简介（由申请人提供）：摘要摘要Second Sight(r) Medical Products, Inc. （SSMP）已经开发视网膜假体超过10年。目前，该公司正在赞助其Argus(tm) II系统的可行性临床试验-一种60电极视网膜假体，用于治疗晚期视网膜色素变性（RP）。该试验招募了32名受试者，其中14名来自美国。商业化道路的下一步将是在美国进行上市前批准临床研究（PMA）。为了进行这样的研究，必须确定预定义的终点，以衡量基本视觉功能和视觉性能在现实世界任务中的改善。目前，对严重视力受损个体的视力进行量化的公认措施很少，也没有建立标准化的终点来确定PMA试验的成功结果。这些都是商业化的重大障碍，因为PMA试验的成功完成以及视觉功能和视觉表现的有意义改善的证明对Argus(tm) II等视网膜假体的商业成功至关重要。我们建议开发新的测试方法来量化视力的改善，并为PMA研究定义有意义的终点。凭借我们丰富的临床经验，我们在开展这项研究方面具有独特的优势。此外，我们建议开发一套软件和硬件工具来进行这些评估，并将其提供给其他美国低视力研究人员。我们的具体目标的成功完成将导致关键试验的进行，这是Argus(tm) II视网膜假体商业化的下一步，旨在显着改善成千上万目前没有其他治疗方式的美国人的生活质量。

DESCRIPTION (provided by applicant): Summary Abstract Second Sight(r) Medical Products, Inc. (SSMP) has been developing retinal prostheses for over 10 years. Currently, the company is sponsoring a feasibility clinical trial for its Argus(tm) II system - a 60 electrode retinal prosthesis to treat advanced retinitis pigmentosa (RP). This trial has enrolled 32 subjects, including 14 subjects in the United States. The next step on the path to commercialization will be to conduct a Pre-Market Approval clinical study (PMA) in the U.S. In order to conduct such a study, pre-defined endpoints must be identified to measure improvements in basic visual function and visual performance on real-world tasks. Today, few accepted measures exist for quantifying the vision of severely visually impaired individuals, and no standardized endpoints have been established to determine a successful outcome for a PMA trial. These represent significant barriers to commercialization because successful completion of a PMA trial and demonstration of meaningful improvements in visual function and visual performance are critical to the commercial success of a retinal prosthesis like the Argus(tm) II. We propose to develop new testing methodologies to quantify improvements in vision and define meaningful endpoints for a PMA study. With our extensive clinical experience, we are uniquely positioned to carry out this research. In addition, we propose to develop a suite of software and hardware tools with which to perform these assessments, and to make them available to other U.S.-based low vision researchers. Successful completion of our specific aims will result in allowing a pivotal trial to proceed, which is the next step in the commercialization of the Argus(tm) II retinal prosthesis, which is aimed at significantly improving the quality of life for tens of thousands of Americans who currently have no alternative form of treatment. PUBLIC HEALTH RELEVANCE: Project Narrative is not required for BRDG-SPAN