Research/Development of Artificial Rentinas for the Blind

描述(申请人提供)：该BRP的长期目标仍然是开发一种临床上有用的视网膜假体，用于因视网膜外变性而失明的患者，如视网膜色素变性和黄斑变性。在第一个资助期，我们不仅完成了我们的所有目标，包括创建和长期动物测试的全功能16电极原型系统，而且在FDA批准的研究中，我们还成功地将该设备植入了6名受试者，这是世界上唯一活跃的长期视网膜假体。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。通过将视网膜变性动物模型中的电生理记录与人类受试者的临床实验进行独特的配对，我们将使用该设备：2.确定电极阵列设计规格，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对眼睛跟踪的需求。最后，我们将3.设计、测试并植入下一代视网膜假体，以恢复有用的视力。为了实现这些具有挑战性但可以实现的目标，这项提案汇集了一支复杂的多学科团队，其中包括一个非营利性基金会(AMF，拥有30多年的植入性设备专业知识和专门设施)、三个学术机构(南加州大学人体临床测试和膜片钳生理学；Doheny Eye Institute用于外科和大型动物研究；以及Salk Institute用于多电极生理学)和一家私人公司(Second Sight公司，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我们的目标，即为许多失明患者提供一种目前尚不存在的重要疗法。

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.