Widefield OCTA Supplement for R43EY034418

R43EY034418 的宽场 OCTA 补充品

• 批准号: 10867770
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 19.66万
• 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/10867770
• 关键词: Address; Administrative Supplement; Adult; Affect; Anesthesia procedures; Angiography; Area; Award; Blindness; Blood Vessels; Caregivers; Caring; Child; Clinic; Computer software; Contrast Media; Data; Development; Devices; Diagnostic; Disease; Examination Under Anesthesia; Eye; Eye diseases; Feedback; Fluorescein Angiography; Funding; Head; Image; Imaging Device; Imaging technology; Infant; Institutional Review Boards; Ischemia; Light; Lighting; Monitor; Motion; Multi-site clinical study; Optical Coherence Tomography; Outcome; Parents; Patients; Performance; Perfusion; Peripheral; Persons; Phase; Physicians; Positioning Attribute; Protocols documentation; Research; Research Proposals; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; Sampling; Scanning; Scientist; Small Business Innovation Research Grant; Speed; System; Systemic disease; Time; Tissues; Underserved Population; United States National Institutes of Health; Update; Validation; Vascular Diseases; Visual impairment; Visualization software; Work; diagnosis standard; diagnostic tool; high risk; imaging capabilities; imaging probe; improved; interest; light weight; neonatal hypoxic-ischemic brain injury; neovascular; neovascularization; neurovascular; novel; older patient; parent grant; patient population; pediatric patients; portability; prototype; retinal imaging; tool; 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，灌注和新血管形成的全身性和眼疾病是 在全球数百万人中，可预防的原因导致中度至严重视力障碍。而许多成年人 可以与高级视网膜成像一起合作并保持仍在 幼儿和老年患者，由于疾病，流动性，麻醉或其他各种原因，他们都是 无法合作（I/Y/UC患者）不能合作。这些患者通常是最小和/或最病的患者 可能影响眼睛的血管，神经血管或缺血性疾病的最高风险。 目前，这些患者无法访问将提供有价值的高级成像技术 诊断信息，将有助于促进我们对疾病的理解。光学连贯性 断层扫描（OCT）是视网膜疾病诊断的黄金标准。 OCT血管造影（OCTA）是功能 无需的无需视网膜微脉管系统的非侵入性，深度分解成像的OCT扩展 用于外源对比剂。由于其密集的采样要求，Octa需要长时间扫描，并且 可以稳定头和眼睛的兼容患者。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在Chinrest上定位。我们相信 超高速度商业手持式八颗设备的开发将提供 医生是对这些服务不足的患者进行成像的宝贵研究和诊断工具。 在先前的NIH资金下，Theia Imaging开发了T1系统，T1系统是一种便携式OCT设备 轻巧的HH-OCT探针。在这里，我们建议开发T1-A，这是T1的超高速度 可以将最新的八颗成像带到床边的系统。这将通过以下 具体目标。 AIM 1：开发超高速度手持式八颗系统。我们将发展一个超级 高速OCT设备通过在现有T1 OCT中升级组件来升级组件。目标2：八八的发展 采集和处理软件。我们将开发八角捕获和可视化软件，包括 新颖的高速瞄准模式，即使在这些极高的扫描中，也能够提供实时反馈 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可行性 评估T1-A系统的性能。 该提案的预期结果是开发超高速度的手持式八片成像 工具，准备供临床医生科学家和护理人员收集否则将是的血管数据 无法访问。该工具将改善这些服务不足的人群的护理。成功完成后 该项目，我们将向系统提交后续II阶段建议，构建其他原型设备， 并与合作者合作进行多中心临床研究，以获取510（k）的必要验证数据 和其他监管清除。