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

光学相干断层扫描(OCT)是成人视网膜诊断和监测的标准 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、幼儿和无法合作的患者(I/YC/UC患者)。因为这些病人不能 交流视力障碍，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。其中一组患者是早产儿，有患心脏病的风险 早产儿视网膜病变(ROP)，占新生儿总数的1.4%。目前，大多数成像 I/YC/UC患者接受可见光眼底成像，这是以前成人护理的标准。那里 I/YC/UC患者(包括患者)使用可见眼底相机进行检查是否存在显著缺陷 不适、压力(特别是对婴儿)和图像伪影(眩光，眼底低对比度) 色素沉着等)这使得对这些图像的评估具有挑战性。华侨城并没有受到这些缺点的影响。 此外，商用手持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 与现有的商业设备相比：(1)它们笨重而缓慢；(2)与之相比，它们的视野(FOV)有限 用于广视场眼底相机；以及(3)几乎不提供图像分析能力。我们相信， 具有可互换宽域的商用手持OCT系统的开发 成像提示和图像分析功能将显著提高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。 泰亚成像公司由一个开发HH-OCT系统的专家团队领导。我们的长期目标是 成像系统的开发将把最先进的成像能力带到I/YC/UC的床边 病人。这些系统将减少在麻醉下进行检查的需要，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 Imagine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：一种符合人体工程学的高速用户- 友好的手持OCT系统，提高I/YC/UC患者的护理水平。在此小型企业中 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3。特定的 目的1：研制非接触式和宽视场接触式模块化手持式OCT探头。 我们将开发一种模块化、宽领域、可与现有T1系统互换的触点，以及 新的宽视野扫描模式。具体目标2：发展宽域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 大范围数据的分割/可视化算法。这项提议的预期结果是 开发可向临床医生提供诊断信息的宽领域HH-OCT系统和软件。

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.