Widefield OCTA Supplement for R43EY034418

影响视网膜血管发育、灌注和新生血管的系统和眼部疾病 全球数百万人中有中到重度视力障碍的可预防原因。虽然很多成年人 可以配合并保持静止以进行先进的视网膜成像，相当数量的患者包括婴儿， 年幼的儿童和年长的患者，由于疾病、行动不便、麻醉或各种其他原因， 无法合作(I/Y/UC患者)不能。这些患者通常是最年轻和/或病情最重的患者。 他们是血管、神经血管或缺血性疾病的最高风险者，这些疾病会影响眼睛。 目前，这些患者无法获得先进的成像技术，这些技术将提供有价值的 提供诊断信息，并将有助于增进我们对其疾病的了解。光学相干性 断层扫描(OCT)是诊断视网膜疾病的金标准。OCT血管成像(OCTA)是一种功能性 扩展OCT，无需对视网膜微血管进行非侵入性、深度分辨率成像 用于外源性造影剂。由于其密集的采样要求，OCTA需要长时间的扫描和 能够保持头部和眼睛稳定的顺从患者。虽然大型桌面系统可以简化成像 有了主动跟踪，I/Y/UC患者通常不能在扫描期间处于下巴休息状态。我们相信 超高速商用手持OCTA设备的开发将提供 医生是对这些服务不足的患者进行成像的有价值的研究和诊断工具。 在NIH之前的资助下，Theia Image开发了T1系统，这是一种便携式OCT设备，具有 轻质HH-OCT探头。在这里，我们建议开发T1-A，这是对T1的超高速升级 可将最先进的OCTA成像技术带到床边的系统。这将通过以下方式实现 明确的目标。目标1：超高速手持OCTA系统的研制。我们将开发一种超 通过升级现有T1 OCT中的组件来实现高速OCT设备。目标2：OCTA的发展 采集处理软件。我们将开发OCTA捕获和可视化软件，包括 新颖的高速瞄准模式，即使在这些极高扫描的情况下也能提供实时反馈 费率。目的3：验证性研究。我们将通过进行验证研究来论证系统的可行性 评估T1-A系统的性能。 这项提议的预期结果是开发一种超高速、手持OCTA成像 工具，供临床医生、科学家和护理人员用来收集血管数据，否则将 无法接近。这一工具将改善这些未得到充分服务的人群的护理。在成功完成后 在这个项目中，我们将向系统提交后续的第二阶段提案，建造更多的原型设备， 并与合作者合作执行多中心临床研究，以获得510(K)的必要验证数据 以及其他监管许可。

Systemic and ocular diseases affecting retinal vascular development, perfusion, and neovascularization are preventable causes of moderate to severe vision impairment in millions of people worldwide. While many adults can cooperate with and hold still for advanced retinal imaging, a significant number of patients including infants, young children, and older patients who, due to sickness, mobility, anesthesia, or a variety of other reasons, are unable to cooperate (I/Y/UC patients) cannot. These patients are often the youngest and/or sickest patients who are at the highest risk of vascular, neurovascular, or ischemic disease that can affect the eye. At present, these patients cannot access advanced imaging technologies that would provide valuable diagnostic information and would contribute to advancing our understanding of their diseases. Optical coherence tomography (OCT) is the gold standard for diagnosis of retinal diseases. OCT angiography (OCTA) is a functional extension of OCT that enables non-invasive, depth resolved imaging of retinal microvasculature without the need for exogenous contrast agents. Because of its dense sampling requirements, OCTA requires long scans and compliant patients who can hold their head and eyes steady. While large tabletop systems can simplify imaging with active tracking, I/Y/UC patients typically cannot position at a chinrest for the duration of the scan. We believe that the development of an ultra-high-speed commercial handheld OCTA device would provide physicians a valuable research and diagnostic tool for imaging of these underserved patients. Under previous NIH funding, Theia Imaging has developed the T1 system, a portable OCT device with a light-weight HH-OCT probe. Here, we propose to develop the T1-A, an ultra-high-speed upgrade to the T1 system that can bring state-of-the-art OCTA imaging to bedside. This will be achieved through the following Specific Aims. Aim 1: Development of an ultra-high-speed handheld OCTA system. We will develop an ultra- high-speed OCT device by upgrading components in the existing T1 OCT. Aim 2: Development of OCTA acquisition and processing software. We will develop OCTA capture and visualization software, including a novel high-speed aiming mode and capable of providing real-time feedback, even at these extremely high scan rates. Aim 3: Validation study. We will demonstrate system feasibility by conducting a validation study evaluating the performance of the T1-A system. The expected outcome of this proposal is the development of an ultra-high-speed, handheld OCTA imaging tool, ready for clinician-scientists and caregivers to use to gather vascular data that would otherwise be inaccessible. This tool will improve the care of these underserved populations. Upon successful completion of this project, we will submit a follow-on Phase II proposal to the system, construct additional prototype devices, and work with collaborators to perform a multi-center clinical study to obtain necessary validation data for 510(k) and other regulatory clearances.