Preclinical preparation for the Boston retinal implant device

描述（由申请人提供）：本提案旨在对我们在哈佛医学院和麻省理工学院的团队设计和组装的视网膜假体进行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失明，无论是色素性视网膜炎（RP）或年龄相关性黄斑变性（AMD）。目前还没有治疗方法可以恢复这两种疾病的视力，尽管其他领域的研究也为帮助这些患者提供了一些希望。RP是世界上遗传性失明的主要原因，尤其具有破坏性，因为它会导致整个视野的视力逐渐丧失

DESCRIPTION (provided by applicant): This proposal seeks to conduct FDA-required "pre-clinical" testing of a retinal prosthesis 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 t the brain via the optic nerve. The primary goal of this prosthesis is to improve the quality-of-lie of severely blind patients by allowing them to navigate in unfamiliar environments. Once achieved, the device also has the potential to facilitate other activities of daily living, like reding street signs, 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. 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 device.