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

描述(由申请人提供)：摘要第二视觉(R)医疗产品公司(SSMP)已经开发视网膜假体超过10年了。目前，该公司正在为其Argus(Tm)II系统赞助一项可行性临床试验，这是一种治疗晚期视网膜色素变性(RP)的60电极视网膜假体。本次试验共招募了32名受试者，其中14名受试者在美国。商业化道路上的下一步将是在美国进行上市前批准临床研究(PMA)。为了进行此类研究，必须确定预定义的终点，以衡量在实际任务中基本视觉功能和视觉表现的改善。今天，几乎没有公认的方法来量化严重视障患者的视力，也没有建立标准的终点来确定PMA试验的成功结果。这些都是商业化的重大障碍，因为PMA试验的成功完成和视觉功能和视觉表现的有意义的改善是像Argus(Tm)II这样的视网膜假体商业成功的关键。我们建议开发新的测试方法来量化视力的改善，并为PMA研究确定有意义的终点。凭借我们丰富的临床经验，我们处于开展这项研究的独特地位。此外，我们建议开发一套用于执行这些评估的软件和硬件工具，并将其提供给其他美国的低视力研究人员。我们的特定目标的成功完成将使一项关键试验得以进行，这是Argus(Tm)II视网膜假体商业化的下一步，该假体旨在显著提高数万目前没有替代治疗形式的美国人的生活质量。 公共卫生相关性：BRDG-SPAN不需要项目说明

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