A High-Speed, User-Friendly, Handheld OCT System for Patients who are Unable to Cooperate

适用于无法合作的患者的高速、用户友好型手持式 OCT 系统

• 批准号: 10706431
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 99.21万
• 依托单位: THEIA IMAGING LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706431
• 关键词: Adoption; Adult; Age related macular degeneration; Anesthesia procedures; Blindness; Caring; Child; Classification; Clinical; Communication; Computer software; Computers; Custom; Data; Development; Devices; Diabetic Retinopathy; Diagnosis; Disease; Examination Under Anesthesia; Exclusion; Eye; Eye diseases; Feedback; Goals; Head; Healthcare; Human; Image; Industrialization; Infant; Infant Care; Injections; Intensive Care; International; Medical Device; Molds; Monitor; Nerve; Newborn Infant; Optic Disk; Optical Coherence Tomography; Outcome; Pathway interactions; Patient Care; Patients; Phase; Pilot Projects; Point-of-Care Systems; Population; Positioning Attribute; Premature Infant; Production; Pupil; Refractive Errors; Reporting; Research; Research Personnel; Rest; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; School-Age Population; Side; Small Business Innovation Research Grant; Speed; System; Time; Training; Translations; United States National Institutes of Health; Vision; Visual impairment; Visualization; Weight; arm; awake; commercialization; cost; design; diagnosis standard; disability; disease diagnosis; ergonomics; imager; imaging modality; improved; insight; light weight; manufacture; non-invasive imaging; optic nerve disorder; optical imaging; physically handicapped; point of care; portability; programs; prototype; quality assurance; retinal imaging; sample fixation; screening; standard of care; stem; usability; user-friendly

ABSTRACT Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal and optic nerve diseases. Clinical OCT systems (large tabletop devices with chinrest) require a compliant subject, and thus are not suitable for use with infants, young children, and patients who are unable to cooperate for eye imaging (such as from physical disability or while under anesthesia or in intensive care). As many of these patients cannot communicate about vision disturbance or vision loss, diagnosis of disease is difficult to achieve before irrevocable vision loss occurs. One example of this population is preterm infants in intensive care and who are at risk for retinopathy of prematurity (ROP). While handheld OCT (HH-OCT) has led to significant insights into the development of ROP, its use for disease screening has been limited in part due to poor usability of the existing commercial systems due to weight, ergonomics and speed of imaging. The need for image-based classification of ROP was a subject of the recent International Classification of ROP Committee. There is a clear need for a commercial, point of care, high-speed, user-friendly handheld OCT system to improve the standard of care for infants, young children, and patients who are unable to cooperate for imaging. Theia Imaging is pursuing commercialization of the Theia 2 high-speed, portable, user-friendly, hand-held OCT system for use in these patients. Our long-term objective is to enable clinicians and researchers to gather much-needed OCT imaging of the retina and/or optic nerve head in their patients. This will decrease the need for examinations under anesthesia and simplify access to valuable information about the retina and optic nerve head at the time of eye care and general health care. This Phase II effort will build on the Theia 1 system developed in the Phase I, to result in an FDA- submission for a handheld system that is lightweight, with a small, ergonomic handpiece and imaging at high speed and a robust commercialization pathway. Theia Imaging will achieve this through the following Aims: Aim 1: Refine the T1 Prototype into a Commercial Medical Device. We will refine both the design of the probe and OCT engine allowing us to scale to production quantities and reduce the overall cost of the device. Aim 2: Refine the T1 Software into a Commercial Product. We will refine this software under a software quality assurance system and improve usability. Aim 3: Pilot Study, Pivotal Study and 510(k) Submission. With the refined Theia 2 system, we will execute pilot and pivotal human studies in support of a 510(k) submission The expected outcome of this proposal is the development of a commercially viable, 300 kHz HH-OCT system and a 510(k) submission for FDA clearance of the device. Both the device and associated software will be designed to be usable by ophthalmic technicians without the need for specialized training.

抽象的 光学相干断层扫描 (OCT) 是诊断和监测视网膜和视网膜病变的金标准 视神经疾病。临床 OCT 系统（带下巴托的大型桌面设备）需要一个合规的受试者， 因此不适合婴儿、幼儿以及无法配合用眼的患者使用 成像（例如由于身体残疾或在麻醉或重症监护下）。正如其中许多 患者无法沟通视力障碍或视力丧失，疾病诊断难以实现 在发生不可挽回的视力丧失之前。这一人群的一个例子是重症监护室中的早产儿和 有早产儿视网膜病变 (ROP) 风险的人。虽然手持式 OCT (HH-OCT) 已导致显着 深入了解 ROP 的发展，其在疾病筛查中的应用受到了限制，部分原因是由于 ROP 的性能较差 由于重量、人体工程学和成像速度，现有商业系统的可用性。需要 基于图像的 ROP 分类是最近 ROP 国际分类委员会的一个主题。 显然需要一种商业、现场护理、高速、用户友好的手持式 OCT 系统来 提高对婴儿、幼儿和无法配合成像的患者的护理水平。 Theia Imaging 正在追求 Theia 2 高速、便携式、用户友好型手持式设备的商业化 OCT系统适用于这些患者。我们的长期目标是使临床医生和研究人员能够收集 患者急需的视网膜和/或视神经乳头 OCT 成像。这将减少需要 用于麻醉下检查并简化获取有关视网膜和视神经的宝贵信息 头部当时的眼睛保健和一般保健。 第二阶段的工作将建立在第一阶段开发的 Theia 1 系统的基础上，以产生 FDA- 提交一个手持式系统，该系统重量轻，具有小型、符合人体工程学的手机和高成像 速度和强大的商业化途径。 Theia Imaging 将通过以下目标实现这一目标： 目标 1：将 T1 原型改进为商用医疗设备。我们将完善探头的设计 OCT 引擎使我们能够扩大生产规模并降低设备的总体成本。目标 2： 将 T1 软件改进为商业产品。我们将在软件质量下完善这个软件 保证系统并提高可用性。目标 3：试点研究、关键研究和 510(k) 提交。随着 完善 Theia 2 系统后，我们将执行试点和关键人体研究以支持 510(k) 提交 该提案的预期成果是开发商业上可行的 300 kHz HH-OCT 系统 提交 FDA 批准该设备的 510(k) 申请。该设备和相关软件都将 专为眼科技术人员设计，无需专门培训即可使用。