Research/Development of Artificial Rentinas for the Blind

该BRP的长期目标仍然是开发临床上有用的视网膜假体， 因视网膜色素变性和黄斑变性等外部视网膜变性而失明的患者。在 在第一个资助期内，我们不仅完成了我们所有的目标，包括创造和长期的动物 测试一个功能齐全的16电极原型系统，但我们也成功地植入了六个受试者 在FDA批准的研究中，这是世界上唯一一种有效的长期视网膜假体。 在下一阶段的研究中，我们将：1。完成多功能视网膜前膜的发育 假体（A-60），在动物中测试其可靠性和安全性，并将其植入人体。通过独特的配对 视网膜变性动物模型和人类临床实验的电生理记录 受试者，我们将使用该设备：2。确定电极阵列设计规范，比较视网膜前病变 和视网膜下配置，确定电刺激算法以最大化空间分辨率， 亮度范围，并确定下一代视网膜假体中眼睛跟踪的需求。最后我们 威尔3.设计、测试并植入人类下一代视网膜假体，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，该提案汇集了一个复杂的 多学科团队，包括一个非营利性基金会（AMF，拥有30多年的植入式器械专业知识 和专门设施），三个学术机构（南加州大学的人类临床试验和膜片钳 生理学; Doheny眼科研究所进行外科和大型动物研究;索尔克研究所进行多学科研究。 电极生理学）和私人公司（用于工程研究和开发的SecondSight， 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，为许多盲人患者提供一种重要的治疗， 存在.

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.