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和眼部疾病是 全球数百万人中度至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高级视网膜成像，包括婴儿在内的大量患者， 由于疾病、行动不便、麻醉或各种其他原因而需要接受治疗的幼儿和老年患者 无法合作（I/Y/UC 患者）不能。这些患者通常是最年轻和/或病情最严重的患者 患有影响眼睛的血管、神经血管或缺血性疾病的风险最高的人。 目前，这些患者无法获得先进的成像技术，而这些技术将提供有价值的信息。 诊断信息，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血管造影（OCTA）是一种功能性检查 OCT 的扩展，无需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 通过主动跟踪，I/Y/UC 患者通常无法在扫描期间坐在下巴托上。我们相信 超高速商用手持式 OCTA 设备的开发将提供 医生为这些服务不足的患者进行成像提供了宝贵的研究和诊断工具。 在 NIH 之前的资助下，Theia Imaging 开发了 T1 系统，这是一种便携式 OCT 设备，具有 轻型 HH-OCT 探头。在这里，我们建议开发T1-A，是T1的超高速升级版 可以将最先进的 OCTA 成像带到床边的系统。这将通过以下方式实现 具体目标。目标 1：开发超高速手持式 OCTA 系统。我们将开发一种超 通过对现有T1 OCT的组件进行升级，实现高速OCT设备。目标 2：OCTA 的发展 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 费率。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，可供临床医生科学家和护理人员用来收集血管数据，否则这些数据将被收集 无法访问。该工具将改善对这些服务不足人群的护理。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，构建额外的原型设备， 并与合作者合作进行多中心临床研究，以获得510(k)必要的验证数据 和其他监管许可。