Research/Development of Artificial Rentinas for the Blind

盲人人工视网膜的研究/开发

• 批准号: 7289698
• 负责人: Robert Jay Greenberg
• 金额: $ 267.17万
• 依托单位: SECOND SIGHT MEDICAL PRODUCTS, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7289698
• 关键词: Accommodation phosphene; Algorithms; Animal Model; Animal Testing; Animals; Area; Blinded; Canis familiaris; Chronic; Clinic; Clinical; Clinical Research; Code; Collaborations; Computer software; Development; Devices; Effectiveness; Electric Stimulation; Electrodes; Electrophysiology (science); Engineering; Environment; Eye; Eye Movements; Foundations; Funding; Goals; Grant; Head; Head Movements; Human; Image; Implant; Institutes; Institution; Invasive; Learning; Localized; Location; Macular degeneration; Measures; Mechanics; Modeling; Movement; Numbers; Operative Surgical Procedures; Patients; Pattern; Performance; Phase; Physicians; Physiologic pulse; Physiology; Positioning Attribute; Prosthesis; Pulse taking; Range; Rattus; Relative (related person); Research; Research Personnel; Resolution; Retina; Retinal; Retinal Degeneration; Retinitis Pigmentosa; Safety; Scientist; Series; Surface; System; Technology; Testing; Tissues; Vision; Work; blind; design; human subject; implantable device; multidisciplinary; next generation; novel; patch clamp; programs; prototype; relating to nervous system; research and development; research clinical testing; research study; retinal prosthesis; size; tool; visual process; visual processing

DESCRIPTION (provided by applicant): The long term goal of this BRP remains the development of a clinically useful retinal prosthesis for patients blinded by outer retinal degenerations, such as retinitis pigmentosa and macular degeneration. In the first funding period, we not only completed all our aims, including the creation and long-term animal testing of a fully functional 16 electrode prototype system, but we also successfully implanted six subjects with this device, the world's only active long-term retinal prostheses, in a FDA-approved study. In the next phase of our research, we will: 1. Complete the development of a versatile epiretinal prosthesis (A-60), test its reliability and safety in animals, and implant it in humans. Through a unique pairing of electrophysiological recordings in animal models of retinal degeneration and clinical experiments in human subjects, we will use this device to: 2. Determine electrode array design specifications, compare epiretinal and subretinal configurations, determine electrical stimulation algorithms to maximize spatial resolution and brightness range, and determine the need for eye tracking in a next generation retinal prosthesis. Finally, we will 3. Design, test, and implant in humans a next generation retinal prosthesis to restore useful vision. To accomplish these challenging but attainable goals, this proposal brings together a sophisticated multidisciplinary team including a non-profit foundation (AMF, with 30+ years of implantable device expertise and specialized facilities), three academic institutions (USC for human clinical testing and patch-clamp physiology; Doheny Eye Institute for surgical and large animal studies; and The Salk Institute for multi- electrode physiology) and a private company (Second Sight for engineering research and development, manufacturing, and regulatory). Our continued collaboration with engineers, scientists and physicians will allow us to achieve our goal of providing many blind patients with an important therapy where none currently exists.

描述（由申请人提供）：该 BRP 的长期目标仍然是为因外层视网膜变性（例如色素性视网膜炎和黄斑变性）失明的患者开发临床上有用的视网膜假体。在第一个资助期内，我们不仅完成了所有目标，包括创建一个功能齐全的16电极原型系统并进行长期动物测试，而且还成功为六名受试者植入了该设备，这是世界上唯一的活跃长期设备FDA 批准的一项研究中的视网膜假体。在下一阶段的研究中，我们将： 1. 完成多功能视网膜前假体（A-60）的开发，在动物身上测试其可靠性和安全性，并将其植入人体。通过视网膜变性动物模型中电生理记录的独特配对和人类受试者的临床实验，我们将使用该设备： 2. 确定电极阵列设计规范，比较视网膜前和视网膜下配置，确定电刺激算法以最大化空间分辨率和亮度范围，并确定下一代视网膜假体中眼球追踪的需求。最后，我们将 3. 设计、测试并将下一代视网膜假体植入人体，以恢复有用的视力。为了实现这些具有挑战性但可实现的目标，该提案汇集了一支复杂的多学科团队，包括一个非营利基金会（AMF，拥有 30 多年的植入设备专业知识和专业设施）、三个学术机构（南加州大学，负责人体临床测试和贴片研究）。钳生理学；Doheny 眼科研究所（负责外科和大型动物研究）；索尔克研究所（负责多电极生理学）和一家私营公司（Second Sight 负责工程研发、制造和监管）。我们与工程师、科学家和医生的持续合作将使我们能够实现为许多盲人患者提供目前尚不存在的重要治疗方法的目标。