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: 10482623
• 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: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482623
• 关键词: Address; Adoption; Adult; Adverse event; Affect; Algorithms; Anesthesia procedures; Blindness; Blood Vessels; Child; Choroid; Clinical; Color; Computer software; Confusion; Cornea; Data; Development; Devices; Diabetic Retinopathy; Diagnosis; Diagnostic Equipment; Disease; Examination Under Anesthesia; Eye; Eye Movements; Feasibility Studies; Fundus; Fundus photography; Glare; Gold; Image; Image Analysis; Infant; Iris; Lateral; Light; Lighting; Macular degeneration; Monitor; Morphologic artifacts; Newborn Infant; Ophthalmic examination and evaluation; Ophthalmologist; Ophthalmoscopy; Optical Coherence Tomography; Outcome; Participant; Pathway Analysis; Patient Care; Patients; Pattern; Pigmentation physiologic function; Point-of-Care Systems; Population; Premature Infant; Recurrence; Research; Research Personnel; Research Proposals; Resolution; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; Scanning; Small Business Innovation Research Grant; Speculums; Speed; Stress; Structure; Subgroup; System; Systemic disease; Telemedicine; Time; United States National Institutes of Health; Validation; Visible Radiation; Vision; Visualization; Visualization software; Work; clinical care; combat; commercialization; diagnosis standard; diagnostic screening; diagnostic value; disease diagnosis; fundus imaging; image visualization; imaging capabilities; imaging system; improved; insight; lens; neural network; neurodevelopment; novel; pediatric patients; phase 2 study; portability; response; retinal imaging; 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 scan pattern optimized for wide FOV. Specific Aim 2: Development of Widefield OCT Segmentation, Analysis, and Visualization Software. 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 portable, widefield, HH-OCT system and software that can provide valuable 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。然而，大多数临床 OCT 设备都是大型桌面系统，不适合与 婴儿、幼儿和无法配合的患者（I/YC/UC 患者）。由于这些患者无法 沟通他们的视力障碍，这些患者的疾病诊断很难实现 在疾病导致不可挽回的视力丧失之前。其中一组患者是有风险的早产儿 早产儿视网膜病变 (ROP)，占新生儿人口的 1.4%。目前，大多数成像 I/YC/UC 患者接受可见光眼底成像，这是以前的成人护理标准。那里 是使用可见眼底相机对 I/YC/UC 患者（包括患者）进行检查的显着缺点 不适、压力（尤其是婴儿）以及图像伪影的存在（眩光、眼底对比度低） 色素沉着等），这使得图像的评估具有挑战性。 OCT 没有这些缺点。 此外，商业手持式 OCT (HH-OCT) 系统的使用使人们对 ROP 的进展和管理。然而，由于 3 个主要限制，HH-OCT 的采用有限 现有的商业设备：（1）笨重且速度慢； (2) 相比之下，视野 (FOV) 有限 广角眼底相机； (3)几乎不提供图像分析功能。我们相信 开发带有可互换宽视野的商用手持式 OCT 系统 成像尖端和图像分析功能将显着提高 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 由开发 HH-OCT 系统的专家团队领导。我们的长期目标是 成像系统的开发将为 I/YC/UC 床边带来最先进的成像功能 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。在当前 NIH 的支持下，Theia 成像正在解决列出的第一个限制 上述通过 Theia T1 系统的开发和商业化实现：符合人体工程学、高速、用户友好型 友好的手持式 OCT 系统可提高 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来解决限制 2 和 3。具体的 目标 1：开发具有非接触式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、宽视场导电嘴，以及 针对宽视场优化的新颖扫描模式。具体目标 2：开发宽场 OCT 分割， 分析和可视化软件。我们将获取初始数据并开发细分/可视化 广域数据的算法。该提案的预期成果是开发一种便携式、 宽场 HH-OCT 系统和软件可以为临床医生提供有价值的诊断信息。