A Widefield, Handheld OCT system for Patients who are Unable to Cooperate

适用于无法合作的患者的宽视野手持式 OCT 系统

• 批准号: 10647616
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 14.56万
• 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: 2022-05-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10647616
• 关键词: Address; Administrative Supplement; Adoption; Adult; Algorithms; Award; Blindness; Clinical; Clinical Data; Color; Computer software; Data; Data Security; Database Management Systems; Development; Devices; Diagnosis; Diagnostic; Digital Imaging and Communications in Medicine; Disease; Examination Under Anesthesia; Feasibility Studies; Fundus; Fundus photography; Future; Glare; Image; Image Analysis; Imaging Device; Infant; Lateral; Metadata; Monitor; Morphologic artifacts; Newborn Infant; Optical Coherence Tomography; Outcome; Parents; Participant; Patient Care; Patients; Pattern; Phase; Pigmentation physiologic function; Pilot Projects; Population; Premature Infant; Research Proposals; Resolution; Retinal Diseases; Retinopathy of Prematurity; Risk; Scanning; Secure; Small Business Innovation Research Grant; Speed; Standardization; Stress; Structure; System; Technology; Time; United States National Institutes of Health; Validation; Visible Radiation; Vision; Visualization; Visualization software; base; commercialization; data management; data standards; data structure; design; diagnostic value; disease diagnosis; file format; fundus imaging; imaging capabilities; imaging system; improved; innovation; insight; novel; pediatric patients; relational database; screening; standard of care; user-friendly; virtual

Optical coherence tomography (OCT) is the standard of care for the diagnosis and monitoring of adult retinal diseases. However, most clinical OCT devices are large tabletop systems that are not suitable for use with infants, young children, and patients that are unable to cooperate (I/YC/UC patients). As these patients cannot communicate about disturbances to their vision, diagnosis of disease in these patients is difficult to achieve before the disease causes irrevocable vision loss. One group of such patients are preterm infants at risk for retinopathy of prematurity (ROP), who comprise 1.4% of the newborn population. Currently, most imaging of I/YC/UC patients is performed with visible light fundus imaging, the previous standard of care for adults. There are notable drawbacks to examinations with visible fundus cameras in I/YC/UC patients including patient discomfort, stress (particularly for infants), and the presence of image artifacts (glare, low contrast from fundus pigmentation, etc.) that make evaluation of the images challenging. OCT does not suffer from these drawbacks. In addition, the use of commercial handheld OCT (HH-OCT) systems has led to significant insights into the progression and management of ROP. However, HH-OCT has seen limited adoption due to 3 major limitations with existing commercial devices: (1) they are heavy and slow; (2) have limited fields-of-views (FOV) compared to wide-field fundus cameras; and (3) provide virtually no image analysis capability. We believe that the development of a commercial handheld OCT system that comes with an interchangeable widefield imaging tip and image analysis capabilities will significantly improve the diagnostic utility of HH-OCT for screening of diseases such as ROP and ultimately improve the standard of care for I/YC/UC patients. Theia Imaging is led by a team of experts in the development HH-OCT systems. Our long-term objective is the development of imaging systems that will bring state of the art imaging capabilities to the bedside of I/YC/UC patients. These systems will decrease the need for examinations under anesthesia and provide clinicians with valuable diagnostic information. Under current NIH support, Theia imaging is addressing the first limitation listed above via the development and commercialization of the Theia T1 system: an ergonomic, high-speed, user- friendly handheld OCT system to improve the standard of care of I/YC/UC patients. In this Small Business Innovation Research proposal, we propose to address limitations 2 and 3 via the following specific aims. Specific Aim 1: Development of a Modular Handheld OCT Probe with Non-Contact and Widefield Contact Modes. We will develop a modular, widefield, contact tip that can be interchanged with the existing T1 system, and a novel wide FOV scan pattern. Specific Aim 2: Development of Widefield OCT Segmentation, Analysis, and Visualization Software with secure data management. We will acquire initial data and develop segmentation/visualization algorithms for the wide field data. The expected outcomes of this proposal are the development of a widefield, HH-OCT system and software that can provide diagnostic information to clinicians.

光学相干断层扫描（OCT）是用于诊断和监测成人视网膜病变的护理标准。 疾病然而，大多数临床OCT设备是大型桌面系统，不适合与 婴儿、幼儿和无法合作的患者（I/YC/UC患者）。由于这些患者不能 沟通他们的视力障碍，这些患者的疾病诊断很难实现 在疾病造成不可挽回的视力丧失之前一组这样的患者是早产儿， 早产儿视网膜病（ROP），占新生儿人口的1.4%。目前，大多数成像 I/YC/UC患者使用可见光眼底成像进行检查，这是之前成人护理的标准。那里 在I/YC/UC患者（包括患者）中使用可见眼底照相机进行检查的显著缺点 不适、压力（尤其是婴儿）和图像伪影（眩光、眼底对比度低 色素沉着等）这使得对图像的评估具有挑战性。OCT没有这些缺点。 此外，商业手持OCT（HH-OCT）系统的使用已经导致了对OCT的显著洞察。 ROP的进展和管理。然而，HH-OCT由于以下3个主要局限性而采用有限 与现有的商业设备相比：（1）它们很重且速度慢;（2）与现有的商业设备相比，它们的视场（FOV）有限 到宽视野眼底相机;以及（3）几乎不提供图像分析功能。我们认为 开发了一种商用手持式OCT系统，该系统具有可互换的宽视场 成像头和图像分析能力将显著提高HH-OCT的诊断效用 用于筛查ROP等疾病，并最终提高I/YC/UC患者的护理标准。 Theia Imaging由HH-OCT系统开发专家团队领导。我们长远的目标是 开发成像系统，将最先进的成像能力带到I/YC/UC的床边 患者这些系统将减少麻醉下检查的需要，并为临床医生提供 有价值的诊断信息。在目前NIH的支持下，Theia成像正在解决列出的第一个限制 通过Theia T1系统的开发和商业化：符合人体工程学，高速，用户- 友好的手持式OCT系统，以提高I/YC/UC患者的护理标准。在这个小企业 在创新研究提案中，我们建议通过以下具体目标解决限制2和限制3。具体 目标1：开发具有非接触和宽场接触模式的模块化手持式OCT探头。 我们将开发一种可与现有T1系统互换的模块化、宽视野接触尖端， 新颖的宽FOV扫描模式。具体目标2：开发宽视野OCT分割、分析和 具有安全数据管理功能的可视化软件。我们将获得初始数据并开发 用于宽场数据的分割/可视化算法。该提案的预期成果是： 开发宽视场HH-OCT系统和软件，为临床医生提供诊断信息。