Preclinical Testing for the Boston Retinal Prosthesis with Penetrating Electrodes

使用穿透电极的波士顿视网膜假体的临床前测试

• 批准号: 9071517
• 负责人: JOSEPH F. RIZZO
• 金额: $ 79.18万
• 依托单位: MASSACHUSETTS EYE AND EAR INFIRMARY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9071517
• 关键词: Activities of Daily Living; Address; Age related macular degeneration; Animals; Applications Grants; Back; Bionics; Blindness; Boston; Brain; Cellular Phone; Chronic; Clinical Trials; Computer software; Core Assembly; Custom; Devices; Disease; Electric Stimulation; Electrodes; Employee; Engineering; Environment; Expenditure; Eye; Face; Family suidae; Feedback; Female; Future; Glass; Goals; Human; Human Resources; Image; Implant; In Vitro; Individual; Inherited; Institutes; Institution; International; Massachusetts; Nerve; Operative Surgical Procedures; Optic Nerve; Outcome; Patients; Phase; Phase I Clinical Trials; Physiologic pulse; Preclinical Testing; Prosthesis; Qualifying; Quality of life; Reading; Recommendation; Research; Resources; Retina; Retinal Degeneration; Retinitis Pigmentosa; Safety; Signal Transduction; Specific qualifier value; Sterilization; Structure; System; Technology; Test Result; Testing; Time; Training; Vendor; Vision; Visual; Visual Fields; Work; base; biomaterial compatibility; blind; computer design; design; digital; experience; implantation; improved; in vivo; male; medical schools; member; neural prosthesis; pre-clinical; public health relevance; relating to nervous system; research clinical testing; response; retina implantation; retinal prosthesis; safety study; visual process; visual processing

 DESCRIPTION (provided by applicant): This proposal seeks to conduct FDA-required "pre-clinical" testing of a retinal prosthesis with penetrating electrodes designed and assembled by our team at Harvard Medical School and the Massachusetts Institute of Technology. Our retinal prosthesis is designed to restore vision to patients who are blind from either retinitis pigmentosa (RP) or age-related macular degeneration (AMD). There is no treatment to restore lost vision for either disease, although promising research in other fields also offers some hope of being able to help these patients. RP is the leading cause of inherited blindness in the world and is particularly devastating because it causes a slowly progressive loss of vision across the entire visual field of both eyes. AMD, which is the leading cause of blindness in the industrialized world, causes loss of central vision that robs a patient of being able to read or easily recognize faces. Our prosthetic system is composed of two components. The first component is a modified pair of glasses that contains an ultra-small camera that captures details of a visual scene; the glasses are connected to a cell phone-like device that processes the visual images. The digital visual signal and operating power are sent wirelessly to the second component of the prosthetic system, which is implanted around the back of the eye. The implanted component receives the visual signal and a custom-designed computer "chip" uses the incoming operating power to distribute electrical pulses to the retina. These electrical pulses will initiate nerve impulses tothe brain via the optic nerve. The primary goal of this prosthesis is to improve the quality-of-life of severely blind patients by enabling navigation in unfamiliar environments. Once achieved, the device also has the potential to facilitate other activities of daily living, like reading street sgns, addresses on buildings, bathroom designations (i.e. male vs. female), and finding and reaching accurately for glasses, plates, and utensils, among other things. The quality of vision that can be restored depends substantially upon the number of stimulation channels, or "pixels". Our device has the largest number (256) of individually-controllable stimulation channels of any neural prosthetic device in the world. This relatively large number of stimulation channels should provide higher quality vision compared to the other devices. The penetrating electrodes should increase the safety of electrical stimulation and improve the quality of vision over what has been obtained with retinal prosthetic devices that use planar electrodes. Following completion of the work described in this grant proposal, our team would hope to receive an FDA approval to conduct a subsequent Phase I "safety" study of our retinal prosthesis with penetrating electrodes.

 描述（由申请人提供）：本提案旨在对我们在哈佛医学院和马萨诸塞州理工学院的团队设计和组装的具有穿透电极的视网膜假体进行FDA要求的“临床前”测试。我们的视网膜假体旨在恢复视力的患者谁是失明的视网膜色素变性或 (RP)或年龄相关性黄斑变性（AMD）。没有治疗方法可以恢复这两种疾病的视力，尽管其他领域有希望的研究也为这些患者提供了一些帮助。RP是世界上遗传性失明的主要原因，而且特别具有破坏性，因为它会导致双眼整个视野缓慢进行性视力丧失。AMD是工业化国家致盲的主要原因，它导致中央视力丧失，使患者无法阅读或轻松识别面部。我们的假肢系统由两个部件组成。第一个组件是一副经过改造的眼镜，其中包含一个超小型摄像头，可以捕捉视觉场景的细节;眼镜连接到一个类似手机的设备，可以处理视觉图像。数字视觉信号和操作电源被无线发送到假体系统的第二个组件，该组件被植入眼睛后部周围。植入的组件接收视觉信号，一个定制设计的计算机“芯片”使用输入的操作功率将电脉冲分配到视网膜。这些电脉冲将通过视神经向大脑发出神经冲动。该假体的主要目标是提高患者的生活质量 严重失明的患者，使导航在陌生的环境。一旦实现，该设备还具有促进日常生活的其他活动的潜力，例如阅读街道信号、建筑物上的地址、浴室名称（即男性与女性），以及准确地找到和达到玻璃、盘子和器皿等。视觉的质量， 恢复的时间基本上取决于刺激通道或“像素”的数量。我们的设备拥有世界上最多的（256个）可单独控制的刺激通道。与其他设备相比，这种相对大量的刺激通道应该提供更高质量的视觉。穿透电极应该增加电刺激的安全性，并改善视觉质量，超过使用平面电极的视网膜假体装置所获得的视觉质量。在完成本拨款申请中描述的工作后，我们的团队希望获得FDA批准，对我们的视网膜假体进行后续的I期“安全性”研究。