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）是成人视网膜诊断和监测的护理标准 疾病。但是，大多数临床OCT设备是大型桌面系统，它们不适合与 婴儿，幼儿和无法合作的患者（I/YC/UC患者）。因为这些患者不能 关于他们视力的障碍，这些患者的疾病诊断很难实现 在疾病导致不可撤销的视力丧失之前。一组此类患者是有可能的早产儿 早产视网膜病变（ROP），占新生人群的1.4％。目前，大多数成像 I/YC/UC患者是使用可见光的光底面成像进行的，这是成年人先前的护理标准。那里 是I/YC/UC患者（包括患者 不适，压力（尤其是针对婴儿）和图像伪像的存在（眩光，底眼对比度低 色素沉着等）使评估图像具有挑战性。 OCT不会遭受这些缺点。 此外，商业手持OCT（HH-OCT）系统的使用导致了对该系统的重要见解 ROP的进步和管理。但是，由于3个主要限制，HH-OCT的采用有限 使用现有的商业设备：（1）它们沉重而缓慢； （2）比较视野有限（FOV） 到宽阔的眼底摄像头； （3）几乎没有图像分析功能。我们相信 开发商业手持式OCT系统，该系统具有可互换的广场 成像提示和图像分析功能将显着改善HH-OCT的诊断效用 为了筛查ROP等疾病，并最终改善了I/YC/UC患者的护理标准。 Theia成像由开发HH-OCT系统专家团队领导。我们的长期目标是 成像系统的开发将使最先进的成像能力带到I/YC/UC的床边 患者。这些系统将减少在麻醉下进行检查的需求，并为临床医生提供 有价值的诊断信息。在当前的NIH支持下，Theia成像正在解决列出的第一个限制 以上通过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OCT系统，以提高I/YC/UC患者的护理标准。在这个小型企业中 创新研究建议，我们建议通过以下特定目标解决局限性2和3。具体的 AIM 1：开发具有非接触式和广阔接触模式的模块化手持式OCT探针。 我们将开发一个模块化，广阔的接触式提示，可以与现有的T1系统互换，并且 新颖的FOV扫描模式。特定目的2：开发广阔的OCT分割，分析和 具有安全数据管理的可视化软件。我们将获取初始数据并开发 宽场数据的分割/可视化算法。该提案的预期结果是 开发广场，HH-OCT系统和软件，可以向临床医生提供诊断信息。