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）是视网膜和监测视网膜和监测的黄金标准 视神经疾病。临床OCT系统（带有Chinrest的大型桌面设备）需要一个合规的主题， 因此，不适合与婴儿，幼儿和无法合作的患者使用 成像（例如身体残疾或在麻醉或重症监护下）。其中许多 患者无法交流视力障碍或视力丧失，疾病的诊断很难实现 在不可撤销的视力丧失发生之前。这个人群的一个例子是重症监护和 有可能出现预期性病变的风险（ROP）。而手持式OCT（HH-OCT）导致了重要的 对ROP发展的见解，其用于疾病筛查的使用受到限制，部分原因是 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分类是最近国际ROP委员会分类的主题。 显然需要商业，护理点，高速，用户友好的手持式OCT系统 改善无法合作成像的婴儿，幼儿和患者的护理标准。 Theia成像正在追求Theia 2高速，便携式，用户友好，手持式商业化的商业化 这些患者使用的OCT系统。我们的长期目标是使临床医生和研究人员能够聚集 在患者中急需的视网膜和/或视神经头的OCT成像。这将减少需求 在麻醉下进行检查，并简化有关视网膜和视神经的有价值信息的访问 眼部护理和一般医疗保健时。 这二阶段的工作将建立在第I阶段开发的TheiA 1系统上，以导致FDA- 提交轻巧的手持系统，带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成像将通过以下目的实现这一目标： AIM 1：将T1原型改进到商业医疗设备中。我们将完善探针的设计 OCT引擎使我们可以扩展到生产量并降低设备的整体成本。目标2： 将T1软件完善成商业产品。我们将根据软件质量完善该软件 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。与 改进了Theia 2系统，我们将执行飞行员和关键人类研究，以支持510（k）的提交 该提案的预期结果是开发商业上可行的300 kHz HH-OCT系统和 FDA清除设备的510（k）提交。设备和相关软件都将是 专门设计的无需专业培训就可以使用眼科技术人员使用。