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

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)是诊断和监测视网膜病变的金标准。 视神经疾病。大多数临床OCT系统都是大型桌面设备，需要符合要求的对象， 因此不适合婴幼儿和不能配合眼睛的病人使用。 成像(例如由于身体残疾或在麻醉下的眼睛检查期间)。就像其中许多 患者不能就视力障碍或视力丧失进行沟通，这些患者的疾病诊断是 在不可挽回的视力丧失发生之前很难实现。一个例子是早产儿有视网膜病变的风险。 早产儿(ROP)占新生儿人口的1.4%。而手持OCT(HH-OCT)已导致 对ROP发展的重大见解，HH-OCT用于疾病筛查的使用一直受到限制 由于现有商业系统的可用性较差。用这些设备捕捉清醒婴儿的图像 该系统具有挑战性，需要经过大量培训的专门研究人员。有必要建立一个 点式护理，高速、人性化的手持式OCT系统，提高护理水平 婴儿、幼儿和无法配合进行成像的患者。 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 是开发一种护理点、高速、用户友好的手持OCT系统，使临床医生和 研究人员收集急需的视网膜和/或视神经头的OCT成像 病人。这将减少在麻醉下进行检查的需要，并简化有价值的 眼部护理和一般健康护理时有关视网膜和视神经头的信息。 通过以下具体目标，我们将开始翻译这样一个HH-OCT系统的过程， 与商用系统相比，速度、人体工程学和可用性都得到了提高。具体目标1： 开发一种便携式、高速OCT系统，具有符合人体工程学的、用户友好的手持探头。我们会 开发300 khz OCT系统(任何类型的最快医用OCT系统)，具有轻巧、符合人体工程学的 手持探头。具体目标2：开发实时、工作流优化的OCT采集软件。我们会 为300 kHz OCT系统引擎开发实时OCT采集软件和直观的工作流程- 优化的用户界面/用户体验。具体目标3：验证性研究。使用拟议的HH-OCT 该系统将在验证研究中与目前商用的HH-OCT系统进行比较。预期中的 这一提议的结果是开发和验证了高速、用户友好的HH-OCT原型 眼科和验光技术人员无需专业人员即可使用的系统和软件 训练。我们相信，该系统的商业化将极大地提高眼部护理的标准和 为婴幼儿和无法配合眼科成像的患者提供一般保健服务。