Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

针对儿科和新生儿成像进行优化的宽视场共焦扫描激光检眼镜

• 批准号: 10526613
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 24.15万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10526613
• 关键词: Address; Adult; Affect; Age; Applications Grants; Blindness; Child; Childhood; Clinical; Clinical Data; Clinical Research; Color; Computer software; Contact Lenses; Development; Device Designs; Devices; Diagnosis; Disease; Engineering; Enrollment; Examination Under Anesthesia; Exposure to; Eye diseases; Fundus photography; Future; Goals; Hand; Image; Imaging Device; Imaging technology; Infant; Infant Care; Lasers; Light; Lighting; Near-infrared optical imaging; Neonatal; Ophthalmoscopes; Outcome; Outcome Study; Patients; Pattern; Performance; Premature Infant; Research; Research Project Grants; Resolution; Retina; Retinal Diseases; Retinopathy of Prematurity; Scanning; Scientist; Stress; System; Technology; Time; Training; Translations; United States National Institutes of Health; Validation; Visible Radiation; Vision; commercialization; cost; design; diagnostic tool; experience; imaging system; improved; neurodevelopment; novel; portability; primary outcome; prototype; real-time images; response; retinal imaging; sample fixation; satisfaction; screening; software development; standard of care; technology development; usability; volunteer

Infants and young children are unable to communicate about loss or disturbance of vision, making it difficult to diagnose vision-threatening diseases before irrevocable vision loss occurs. Commercially available pediatric retinal imaging technologies, including handheld OCT (HH-OCT) and handheld fundus cameras, can be used to screen for and diagnose eye disease in these young patients; however, these technologies have significant drawbacks, such as poor usability, high cost and/or causing significant patient discomfort and stress. One important application of pediatric retinal imaging is the screening of preterm infants for retinopathy of prematurity (ROP). The development of HHOCT has significantly improved our understanding of the progression of ROP, but its use as a diagnostic tool for ROP has been limited by the high cost and poor usability of commercial systems. Similarly, currently available widefield color fundus cameras are prohibitively expensive, and can be stress inducing due to the use of a contact lens and bright illumination flash. Stress associated with the use of these devices can complicate repeat imaging, as young children quickly develop and aversion response to the device. In addition, repeated exposures to stress has been shown to affect neural development in preterm infants. Thus, capturing images in infants and young children with either of these types of systems is expensive, challenging, requiring specialized research staff with significant training. Clearly, there exists a need for a lower- cost and easier to use pediatric retinal imaging system, ideally one that does not cause stress in pre-term infants. This Exploratory/Developmental Research Grant proposal brings together a team of engineers and clinician- scientists with expertise in ophthalmic imaging technology development and translation to develop a pediatric- specific hand-held scanning laser ophthalmoscope (SLO) to address the shortcomings of current commercially available pediatric retinal imaging devices. This technology will substantially improve the standard of care for infants and young children who are currently underserved by existing technologies. To address this unmet clinical need, we propose to construct a prototype, pediatric-specific SLO device and evaluate its clinical feasibility through the following Specific Aims. Specific Aim 1: Develop a Dual-mode, Widefield SLO System with an Ergonomic Handheld Probe. This device will operate in two modes; a non-contact mode providing a 60° FOV and 18 µm resolution at up to 10 frames per second, and a contact mode employing commercially available single-use contact lenses, providing a 120° FOV and 44 µm resolution, also at up to 10 fps. We will also develop real-time image acquisition and display software. Specific Aim 2: Pilot Clinical Study. Use of the proposed SLO system will be compared to current commercial alternatives, comparing the non-contact mode with a non- contact fundus cameras, and the contact mode with a widefield SLO and a contact, widefield fundus camera. The expected outcome of this proposal is the development and initial validation of a pediatric-specific SLO system that will form the basis of future efforts towards clinical validation and ultimate commercialization.

婴幼儿无法就视力丧失或视力障碍进行交流，这使得他们很难 在发生不可逆转的视力丧失之前诊断出威胁视力的疾病。 视网膜成像技术，包括手持式 OCT (HH-OCT) 和手持式眼底相机，可用于 然而，这些技术对于这些年轻患者的眼部疾病的筛查和诊断具有重要意义。 不稳定，例如可用性差、成本高和/或导致患者明显不适和压力。 儿科视网膜成像的重要应用是筛查早产儿的早产儿视网膜病变 (ROP)。HHOCT 的发展显着提高了我们对 ROP 进展的理解， 但其作为 ROP 诊断工具的使用受到商业化成本高和可用性差的限制。 类似地，目前可用的宽视场彩色眼底相机非常昂贵，并且可能非常昂贵。 由于使用隐形眼镜和使用强光闪光灯而产生的压力。 这些设备可能会使重复成像变得复杂，因为幼儿很快就会对成像产生厌恶反应。 此外，反复承受压力已被证明会影响早产儿的神经发育。 因此，使用这些类型的系统中的任何一种来捕获婴儿和幼儿的图像都是昂贵的， 具有挑战性，需要经过大量培训的专业研究人员，显然，需要较低的水平。 成本低且更易于使用的儿科视网膜成像系统，理想情况下不会给早产儿造成压力。 这项探索性/发展性研究资助提案汇集了工程师和临床医生团队 - 具有眼科成像技术开发和转化专业知识的科学家开发了儿科- 专用手持式扫描激光检眼镜（SLO）解决了目前商业化检眼镜的缺点 这项技术将大大提高儿科视网膜成像设备的护理标准。 目前现有技术服务不足的婴儿和幼儿，以解决这一未得到满足的临床问题。 根据需要，我们建议构建一个儿科专用 SLO 设备原型并评估其临床可行性 通过以下具体目标 1：开发具有双模、宽场 SLO 系统。 符合人体工程学的手持式探头可在两种模式下运行：提供 60° FOV 的非接触模式。 分辨率高达 18 µm，每秒 10 帧，接触模式采用市售的 我们还将开发一次性隐形眼镜，提供 120° FOV 和 44 µm 分辨率，帧速率也高达 10 fps。 实时图像采集和显示软件。具体目标 2：使用所提出的试点临床研究。 SLO 系统将与当前的商业替代方案进行比较，将非接触模式与非接触模式进行比较 接触式眼底相机，以及带有宽场 SLO 和接触式宽场眼底相机的接触式模式。 该提案的预期成果是儿科特定 SLO 的开发和初步验证 该系统将构成未来临床验证和最终商业化努力的基础。