Preclinical Testing for the Boston Retinal Prosthesis with Penetrating Electrodes

 描述(由申请人提供)：这项提案寻求对由我们在哈佛医学院和麻省理工学院设计和组装的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为因视网膜色素变性而失明的患者恢复视力。 (RP)或老年性黄斑变性(AMD)。目前还没有恢复这两种疾病失明的治疗方法，尽管在其他领域有希望的研究也提供了一些能够帮助这些患者的希望。RP是世界上遗传性失明的主要原因，其破坏性特别大，因为它会导致双眼整个视野缓慢进行性的视力丧失。AMD是工业化世界中导致失明的主要原因，它会导致中心视力丧失，使患者无法阅读或轻松识别人脸。我们的假体系统由两部分组成。第一个部件是一副改装的眼镜，其中包含一个捕捉视觉场景细节的超小型摄像头；眼镜连接到一个类似手机的设备，处理视觉图像。数字视觉信号和操作功率被无线发送到假肢系统的第二个组件，该组件被植入眼球后部。植入的组件接收视觉信号，一个定制设计的计算机“芯片”使用输入的工作功率将电脉冲分配给视网膜。这些电脉冲将通过视神经向大脑发出神经脉冲。这种假体的主要目标是改善老年人的生活质量 通过在不熟悉的环境中导航，使患者严重失明。一旦实现，该设备还有可能促进其他日常生活活动，如阅读街道标志、建筑物上的地址、卫生间名称(即男性与女性)，以及准确地找到和接触到玻璃杯、盘子和器皿等。视觉质量可以是 恢复在很大程度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可单独控制的刺激通道(256个)，是所有神经假体设备中最多的。与其他设备相比，这种相对较大数量的刺激通道应该可以提供更高质量的视觉。与使用平面电极的视网膜假体相比，穿透电极应该会增加电刺激的安全性，并改善视觉质量。在完成这项拨款提案中所描述的工作后，我们的团队希望获得FDA的批准，对我们的穿透电极视网膜假体进行后续的I期“安全性”研究。

 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.