Ultrahigh Speed OCT Angiography System for Patients who are Unable to Cooperate

适用于无法配合患者的超高速 OCT 血管造影系统

• 批准号: 10547018
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 25.96万
• 依托单位: THEIA IMAGING LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547018
• 关键词: Adult; Affect; Anesthesia procedures; Angiography; Blood Vessels; Caregivers; Caring; Child; Clinical Research; Computer software; Contrast Media; Data; Development; Developmental Delay Disorders; Devices; Diagnosis; Disease; Dyes; Eye; Feedback; Fluorescein; Fluorescein Angiography; Functional disorder; Funding; Fundus; Fundus photography; Gold; Head; Human; Image; Imaging Device; Imaging technology; Infant; Institutional Review Boards; Intensive Care; Longevity; Motion; Multi-site clinical study; Optical Coherence Tomography; Outcome; Pathologic Nystagmus; Patients; Performance; Perfusion; Persons; Phase; Physicians; Positioning Attribute; Protocols documentation; Research; Research Personnel; Research Proposals; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; Sampling; Scanning; Scientist; Small Business Innovation Research Grant; Speed; Structure; System; Time; Translations; Underserved Population; United States National Institutes of Health; Update; Validation; Vascular Diseases; Visual impairment; Visualization software; Work; awake; design; diagnosis standard; diagnostic tool; diagnostic value; high risk; imager; imaging probe; improved; insight; interest; intravenous injection; light weight; macula; neonatal hypoxic-ischemic brain injury; neovascularization; neurovascular; novel; older patient; patient population; pediatric patients; portability; prototype; retinal imaging; sample fixation; success; three dimensional structure; tool; treatment response; two-dimensional; validation studies

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.

影响视网膜血管发育、灌注和新生血管形成的全身性和眼部疾病是 全世界数百万人中重度视力障碍的可预防原因。虽然许多成年人 可以与先进的视网膜成像合作并保持静止，包括婴儿在内的大量患者， 幼儿和老年患者，由于疾病、行动不便、麻醉或其他各种原因， 无法合作（I/Y/UC患者）。这些患者通常是最年轻和/或病情最严重的患者 这些人患上影响眼睛的血管、神经血管或缺血性疾病的风险最高。 目前，这些患者无法获得先进的成像技术， 诊断信息，并将有助于促进我们对他们的疾病的了解。光学相干 断层扫描（OCT）是诊断视网膜疾病的金标准。OCT血管造影（OCTA）是一种功能性 OCT的扩展，能够对视网膜微血管系统进行非侵入性深度分辨成像， 用于外源性造影剂。由于其密集采样要求，OCTA需要长时间扫描， 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 在主动跟踪的情况下，I/Y/UC患者通常不能在扫描的持续时间内定位在腮托处。我们认为 超高速商用手持OCTA设备的开发将提供 医生是一个有价值的研究和诊断工具，为这些服务不足的患者成像。 在之前的NIH资助下，Theia Imaging开发了T1系统，这是一种便携式OCT设备， 轻型HH-OCT探头。在这里，我们建议开发T1-A，这是T1的超高速升级版 该系统可以将最先进的OCTA成像带到床边。这将通过以下方式实现 具体目标。目标1：开发超高速手持OCTA系统。我们将开发一个超- 通过升级现有T1 OCT中的组件来实现高速OCT设备。目标2：开发OCTA 采集和处理软件。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，即使在极高的扫描速度下也能提供实时反馈 rates.目标3：验证研究。我们将通过进行验证研究来证明系统的可行性 评估T1-A系统的性能。 该提案的预期成果是开发超高速手持式OCTA成像 工具，供临床科学家和护理人员使用，以收集血管数据，否则将 难以接近这一工具将改善对这些得不到充分服务的人口的照顾。成功完成后 这个项目，我们将提交一个后续的第二阶段的建议，该系统，建设更多的原型设备， 并与合作者合作进行多中心临床研究，以获得510（k）的必要验证数据 以及其他监管许可。