权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Preclinical preparation for the Boston retinal implant device

波士顿视网膜植入装置的临床前准备

基本信息

批准号：
9114565
负责人：
JOSEPH F. RIZZO
金额：
$ 19.94万
依托单位：
MASSACHUSETTS EYE AND EAR INFIRMARY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-25 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9114565
关键词：
Activities of Daily Living Address Age related macular degeneration Alpha Cell Animals Applications Grants Back Bionics Blindness Boston Brain Cellular Phone Clinical Clinical Trials Custom Data Devices Disease Documentation Environment Eye Face Female Goals Histologic Human Image Implant In Vitro Income Individual Industrialization Inherited Institutes Laboratories Massachusetts Miniature Swine Nerve Optic Nerve Patients Phase Physiologic pulse Preparation Procedures Prosthesis Prosthesis Design Protocols documentation Research Retina Retinitis Pigmentosa Signal Transduction Software Validation System Technology Testing Vision Visual Visual Fields Wireless Technology Work biomaterial compatibility blind computer design design digital implantable device implantation improved male medical schools neural prosthesis pre-clinical prototype public health relevance research clinical testing retina implantation retinal prosthesis safety study visual process

项目摘要

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.

描述（由申请人提供）：该提案旨在对我们哈佛医学院和麻省理工学院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帮助因色素性视网膜炎 (RP) 或年龄相关性黄斑变性 (AMD) 失明的患者恢复视力。尽管其他领域的有希望的研究也为帮助这些患者带来了一些希望，但目前还没有治疗方法可以恢复这两种疾病失去的视力。 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缓慢进行性视力丧失。双眼。 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，从而使患者无法阅读或轻松识别面孔。我们的假肢系统由两个部分组成。第一个组件是一副经过修改的眼镜，其中包含一个超小型相机，可以捕捉视觉场景的细节；眼镜连接到处理视觉图像的类似手机的设备。数字视觉信号和操作功率被无线发送到植入在眼睛后部周围的假肢系统的第二个组件。植入的组件接收视觉信号，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到视网膜。这些电脉冲将通过视神经向大脑发起神经冲动。该假肢的主要目标是通过允许严重失明患者在陌生的环境中导航来提高他们的谎言质量。一旦实现，该设备还有可能促进其他日常生活活动，例如红色街道标志、建筑物地址、浴室名称（即男性与女性），以及准确找到并拿取玻璃、盘子和餐具等。可以恢复的视觉质量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任何神经假体设备中数量最多 (256) 的独立可控刺激通道。这样的刺激量比较大与其他设备相比，通道应提供更高质量的视觉。完成本拨款提案中描述的工作后，我们的团队希望获得 FDA 的批准，对我们的设备进行后续的第一阶段“安全”研究。