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

视网膜假体低视力评估工具的开发和测试。

• 批准号: 7926853
• 负责人: Robert Jay Greenberg
• 金额: $ 298.82万
• 依托单位: SECOND SIGHT MEDICAL PRODUCTS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7926853
• 关键词: Activities of Daily Living; Address; American; Area; Climacteric; Clinic; Clinical; Clinical Research; Clinical Trials; Complete Blindness; Computer software; Computers; Data; Development; Devices; Economics; Electrodes; Enrollment; FDA approved; Goals; Grant; Individual; Lead; Letters; Light; Marketing; Measures; Medical; Methodology; Methods; Outcome; Patients; Pattern; Perception; Performance; Population; Positioning Attribute; Procedures; Prosthesis; Protocols documentation; Publishing; Quality of life; Recovery; Research; Research Personnel; Retinal; Retinitis Pigmentosa; Safety; Specific qualifier value; Staging; System; Testing; United States; Validation; Vision; Visual Acuity; Visual impairment; abstracting; base; clinically significant; commercialization; experience; flexibility; improved; patient population; public health relevance; retinal prosthesis; skills; software development; success; tool; visual performance

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

描述（由申请人提供）：摘要摘要第二镜头（R）医疗产品，Inc。（SSMP）已经开发了视网膜假体已有10多年的历史了。目前，该公司正在赞助其Argus（TM）II系统的可行性临床试验 - 60个电极性视网膜假体以治疗高级色素炎（RP）。该试验已招募32名受试者，其中包括美国的14名受试者。商业化途径的下一步将是在美国进行市场前批准临床研究（PMA），以进行此类研究，必须确定预定的端点，以衡量实际上对现实世界任务的基本视觉功能和视觉性能的改善。如今，很少有可接受的措施可以量化严重视力障碍的个体的愿景，并且没有建立标准化的终点来确定PMA试验的成功结果。这些代表了商业化的重大障碍，因为成功完成PMA试验以及对视觉功能和视觉性能的有意义改善的证明对于像Argus（TM）II这样的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，以量化视力的改进，并为PMA研究定义有意义的终点。凭借我们丰富的临床经验，我们在进行这项研究方面处于独特状态。此外，我们建议开发一套软件和硬件工具，以执行这些评估，并将其提供给其他基于美国的低视力研究人员。成功完成我们的特定目标将导致进行关键试验进行，这是Argus（TM）II视网膜假体商业化的下一步，该旨在显着提高成千上万目前没有其他治疗方式的美国人的生活质量。 公共卫生相关性：BRDG-SPAN不需要项目叙述

项目成果

Reading visual braille with a retinal prosthesis.

• DOI: 10.3389/fnins.2012.00168
• 发表时间: 2012
• 期刊: Frontiers in neuroscience
• 影响因子: 4.3
• 作者: Lauritzen TZ;Harris J;Mohand-Said S;Sahel JA;Dorn JD;McClure K;Greenberg RJ
• 通讯作者: Greenberg RJ

FLORA™: Phase I development of a functional vision assessment for prosthetic vision users.

• DOI: 10.1111/cxo.12242
• 发表时间: 2015-07
• 期刊: Clinical & experimental optometry
• 影响因子: 1.9
• 作者: Geruschat DR;Flax M;Tanna N;Bianchi M;Fisher A;Goldschmidt M;Fisher L;Dagnelie G;Deremeik J;Smith A;Anaflous F;Dorn J
• 通讯作者: Dorn J