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: 10152298
• 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: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10152298
• 关键词: Address; Adoption; Age related macular degeneration; Angiography; Archives; Blindness; Businesses; Caring; Child; Clinical; Computer software; Data; Development; Devices; Diagnosis; Diagnostic; Disease; Examination Under Anesthesia; Eye; Eye diseases; Feedback; Generations; Gold; Healthcare; Image; Infant; Infant Care; Intensive Care; Intuition; Legal patent; Medical; Monitor; Multicenter Studies; Newborn Infant; Operating System; Ophthalmic examination and evaluation; Optic Disk; Optic Nerve; Optical Coherence Tomography; Outcome; Patients; Phase; Point-of-Care Systems; Population; Positioning Attribute; Premature Infant; Process; Psyche structure; Publications; Publishing; Pupil; Reading; Refractive Errors; Research; Research Personnel; Research Proposals; Resolution; Rest; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; School-Age Population; Small Business Innovation Research Grant; Speed; Supination; System; Technology; Time; Training; Translating; Translations; United States National Institutes of Health; Validation; Vision; Visual impairment; Voice; Work; awake; base; commercialization; design; diabetic; diagnosis standard; disease diagnosis; ergonomics; experience; fovea centralis; imager; imaging modality; improved; insight; light weight; non-invasive imaging; novel; optic nerve disorder; patient population; pediatric patients; physically handicapped; point of care; portability; programs; prototype; retinal imaging; screening; standard of care; stem; usability; user-friendly; validation studies; Address; Adoption; Age related macular degeneration; Angiography; Archives; Blindness; Businesses; Caring; Child; Clinical; Computer software; Data; Development; Devices; Diagnosis; Diagnostic; Disease; Examination Under Anesthesia; Eye; Eye diseases; Feedback; Generations; Gold; Healthcare; Image; Infant; Infant Care; Intensive Care; Intuition; Legal patent; Medical; Monitor; Multicenter Studies; Newborn Infant; Operating System; Ophthalmic examination and evaluation; Optic Disk; Optic Nerve; Optical Coherence Tomography; Outcome; Patients; Phase; Point-of-Care Systems; Population; Positioning Attribute; Premature Infant; Process; Psyche structure; Publications; Publishing; Pupil; Reading; Refractive Errors; Research; Research Personnel; Research Proposals; Resolution; Rest; Retina; Retinal Diseases; Retinopathy of Prematurity; Risk; School-Age Population; Small Business Innovation Research Grant; Speed; Supination; System; Technology; Time; Training; Translating; Translations; United States National Institutes of Health; Validation; Vision; Visual impairment; Voice; Work; awake; base; commercialization; design; diabetic; diagnosis standard; disease diagnosis; ergonomics; experience; fovea centralis; imager; imaging modality; improved; insight; light weight; non-invasive imaging; novel; optic nerve disorder; patient population; pediatric patients; physically handicapped; point of care; portability; programs; prototype; retinal imaging; screening; standard of care; stem; usability; user-friendly; validation studies

Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal and optic nerve diseases. Most clinical OCT systems are large tabletop devices that 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 during eye examination under anesthesia). As many of these patients cannot communicate about vision disturbance or vision loss, diagnosis of disease in these patients is difficult to achieve before irrevocable vision loss occurs. One example is preterm infants at risk for retinopathy of prematurity (ROP) who make up 1.4% of the newborn population. While handheld OCT (HH-OCT) has led to significant insights into the development of ROP, the use of HH-OCT for disease screening has been limited due to the poor usability of existing commercial systems. Capturing images in awake infants with these systems is challenging, requiring specialized research staff with significant training. There is a need for a point of care, high-speed, user-friendly handheld OCT system to improve the standard of care of infants, young children, and patients who are unable to cooperate for imaging. Theia Imaging is led by a team of experts in the development HH-OCT systems. Our long-term objective is to develop a point of care, high speed, user-friendly, handheld OCT system to enable clinicians and researchers to gather much-needed OCT imaging of the retina and/or optic nerve head of 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. Through the following specific aims, we will begin the process of translating such an HH-OCT system, with improved speed, ergonomics, and usability as compared to commercially available systems. Specific Aim 1: Develop a Portable, High-Speed OCT System with Ergonomic, User-Friendly Handheld Probe. We will develop a 300 kHz OCT system (the fastest medical OCT system of any kind) with a lightweight, ergonomic handheld probe. Specific Aim 2: Develop Real-Time, Workflow-Optimized OCT Capture Software. We will develop real time, OCT acquisition software for the 300 kHz OCT system engine and an intuitive workflow- optimized user interface/user experience. Specific Aim 3: Validation Study. Use of the proposed HH-OCT system will be compared to current commercial HH-OCT systems in a validation study. The expected outcome of this proposal is the development and validation of a prototype high-speed, user-friendly HH-OCT system and software usable by ophthalmic and optometric technicians without the need for specialized training. We believe that the commercialization of this system will greatly improve the standard of eye care and general health care for infants, young children and patients unable to cooperate for eye imaging.

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。大多数临床OCT系统是大型桌面设备，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下眼睛检查期间）。其中许多 患者无法就视力障碍或视力丧失进行交流，这些患者疾病的诊断是 在不可撤销的视力丧失发生之前很难实现。一个例子是早产儿，患有视网膜病的风险 占新生儿1.4％的早产（ROP）。而手持式OCT（HH-OCT）已导致 对ROP发展的重要见解，将HH-OCT用于疾病筛查一直受到限制 由于现有商业系统的可用性差。用这些捕获清醒婴儿的图像 系统具有挑战性，需要进行大量培训的专业研究人员。需要一个 护理点，高速，用户友好的手持式OCT系统，以提高护理标准 婴儿，幼儿和无法合作成像的患者。 Theia成像由开发HH-OCT系统专家团队领导。我们的长期目标 是要开发一个护理点，高速，用户友好的手持式OCT系统，以使临床医生和 研究人员收集了急需的视网膜和/或视神经头的OCT成像 患者。这将减少在麻醉下进行检查的需求，并简化获得有价值的访问 在眼保健和一般医疗保健时，有关视网膜和视神经头的信息。 通过以下特定目标，我们将开始转换这种HH-OCT系统的过程 与市售系统相比，提高了速度，人体工程学和可用性。具体目标1： 开发具有符合人体工程学的，用户友好的手持式探针的便携式高速OCT系统。我们将 开发一个300 kHz OCT系统（任何类型的最快的医疗OCT系统），具有轻巧的人体工程学 手持式探针。特定目标2：开发实时，工作流程优化的OCT捕获软件。我们将 为300 kHz OCT系统发动机和直观的工作流程开发实时的实时收购软件 - 优化的用户界面/用户体验。特定目标3：验证研究。使用建议的HH-OCT 在验证研究中，将将系统与当前的商业HH-OCT系统进行比较。预期 该建议的结果是原型高速，用户友好的HH-OCT的开发和验证 通过眼科和验光技术人员可用的系统和软件，无需专业 训练。我们认为，该系统的商业化将大大提高眼保健标准和 婴儿，幼儿和患者的一般医疗保健无法合作进行眼部影像。