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.

婴儿和幼儿无法就视力丧失或视力灾难进行交流，这使它变得困难 在发生不可撤销的视力丧失之前，诊断威胁性疾病。市售的小儿 视网膜成像技术，包括手持式OCT（HH-OCT）和手持式眼底摄像头，可用于 筛选和诊断这些年轻患者的眼病；但是，这些技术具有重要的 缺点，例如差的可用性，高成本和/或引起严重的患者不适和压力。一 小儿视网膜成像的重要应用是对早产儿的早产儿的筛查 （ROP）。 HHOCT的发展显着改善了我们对ROP进展的理解， 但是它用作ROP的诊断工具受到了高成本和商业可用性差的限制 系统。同样，当前可用的广场彩色眼镜摄像头禁止昂贵，并且可以是 由于使用隐形眼镜和明亮的照明闪光而引起的压力。与使用相关的压力 这些设备会使重复成像复杂化，因为幼儿迅速发展并厌恶对 设备。此外，已经证明反复暴露于压力会影响早产的神经发展 婴儿。那，捕获这些类型的系统中的婴儿和幼儿中的图像很昂贵， 具有挑战性，需要专业的研究人员进行大量培训。显然，存在较低的需要 成本且易于使用小儿视网膜成像系统，理想情况下，这种成像不会导致前婴儿的压力。 该探索性/发展研究赠款提案汇集了一个工程师和临床团队 具有眼科成像技术开发和翻译方面的专业知识的科学家，以发展儿科 特定的手持式扫描激光眼镜镜（SLO），以解决当前商业上的缺点 可用的小儿视网膜成像设备。该技术将大大改善护理标准 目前因现有技术服务不足的婴儿和幼儿。解决这个未得到满足的临床 需要，我们建议构建原型，小儿特异性SLO设备并评估其临床可行性 通过以下特定目标。特定目的1：开发一个双模式，宽阔的SLO系统 人体工程学手持探针。该设备将以两种模式运行；提供60°FOV的非接触模式 每秒最多10帧的分辨率和18 µm的分辨率，以及使用市售的接触模式 一次性隐形眼镜，可提供120°FOV和44 µM的分辨率，也可达10 fps。我们还将发展 实时图像采集和显示软件。特定目标2：试点临床研究。拟议的 将SLO系统与当前的商业替代方案进行比较，将非接触模式与非 - 与宽阔的SLO和接触式宽阔的Fordfield镜头相机，请与Felcus摄像机进行联系，并接触模式。 该提案的预期结果是儿科特异性SLO的开发和初始验证 系统将构成未来努力临床验证和最终商业化的基础。