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，需要依从的受试者， 因此不适合用于婴儿、幼儿和不能配合眼睛的患者 成像（如身体残疾或在麻醉下进行眼科检查）。因为许多这些 患者不能就视力障碍或视力丧失进行交流，这些患者的疾病诊断是 在不可逆转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 早产儿占新生儿人口的1.4%。虽然手持OCT（HH-OCT）已经导致 尽管对ROP的发展有着重要的见解，但HH-OCT用于疾病筛查的使用受到限制 这是由于现有商业系统的可用性差。用这些捕捉清醒婴儿的图像 系统是具有挑战性的，需要经过大量培训的专业研究人员。需要一种 点护理，高速，用户友好的手持OCT系统，以提高护理标准， 婴儿、幼儿和不能配合成像的患者。 Theia Imaging由HH-OCT系统开发专家团队领导。我们的长期目标 是开发一种即时、高速、用户友好的手持式OCT系统，使临床医生和 研究人员收集他们的视网膜和/或视神经乳头急需的OCT成像， 患者这将减少在麻醉下进行检查的需要，并简化对有价值的 在眼睛护理和一般保健时，有关视网膜和视神经乳头的信息。 通过以下具体目标，我们将开始翻译这种HH-OCT系统的过程， 与商业上可获得的系统相比，提高了速度、人机工程学和可用性。具体目标1： 开发便携式高速OCT系统，配备符合人体工程学的用户友好型手持式探头。我们将 开发300 kHz OCT系统（任何类型的最快医疗OCT系统），具有轻便、符合人体工程学的 手持探头具体目标2：开发实时、工作流程优化的OCT采集软件。我们将 开发用于300 kHz OCT系统引擎的真实的实时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：验证研究。使用申报的HH-OCT 系统将在确认研究中与当前商用HH-OCT系统进行比较。预期 这个建议的结果是开发和验证一个原型的高速，用户友好的HH-OCT 眼科和验光技师无需专业人员即可使用的系统和软件 训练我们相信，该系统的商业化将大大提高眼睛护理的标准， 婴儿、幼儿和无法配合眼部成像的患者的一般卫生保健。