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: 10701946
• 负责人: Al-Hafeez Zahir Dhalla
• 金额: $ 20.13万
• 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/10701946
• 关键词: Address; Adult; Affect; Age; Applications Grants; Blindness; Child; Childhood; Clinical; Clinical Data; Clinical Research; Color; Communication; Computer software; Contact Lenses; Decision Making; Dedications; Development; Device Designs; Devices; Diagnosis; Disease; Engineering; Enrollment; Examination Under Anesthesia; Exposure to; Eye diseases; Fundus photography; Future; Goals; 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; design verification; diagnostic tool; ergonomics; experience; imaging system; improved; meter; 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，这使得这一点变得困难 在不可挽回的视力丧失发生之前诊断威胁视力的疾病。市售的儿科药品 包括手持OCT(HH-OCT)和手持眼底相机在内的视网膜成像技术可用于 在这些年轻患者中筛查和诊断眼病；然而，这些技术具有重要的意义 缺点，如可用性差、成本高和/或导致患者严重不适和压力。一 儿童视网膜成像的重要应用是筛查早产儿视网膜病变 (ROP)。HHOCT的发展极大地提高了我们对ROP进展的理解， 但其作为ROP诊断工具的使用一直受到商业成本高和易用性差的限制 系统。同样，目前可用的宽视场彩色眼底相机价格高得令人望而却步，而且可能 由于使用隐形眼镜和明亮的闪光灯而引起的压力。与使用有关的压力 这些设备可能会使重复成像复杂化，因为幼儿很快就会对 设备。此外，反复暴露在压力下也会影响早产儿的神经发育。 婴儿。因此，使用这两种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门研究人员。显然，有必要降低- 儿童视网膜成像系统价格低廉，使用方便，理想情况下不会对早产儿造成压力。 这项探索性/开发性研究资助计划将工程师和临床医生团队聚集在一起- 在眼科成像技术开发和翻译方面具有专业知识的科学家开发了一种儿科- 专用手持扫描激光检眼镜(SLO)解决目前商业化的缺点 现有的儿科视网膜成像设备。这项技术将极大地提高护理标准 目前现有技术服务不足的婴幼儿。来解决这一未满足的临床问题 需要，我们建议构建一个原型，儿科专用的SLO装置，并评估其临床可行性 通过以下具体目标。具体目标1：开发一种双模、宽场SLO系统 人体工程学手持式探头。该设备将在两种模式下运行；一种非接触式模式，提供60°视野 和高达10帧每秒的18微米分辨率，以及采用商用的接触模式 一次性隐形眼镜，提供120°FOV和44微米分辨率，分辨率也高达10fps。我们还将发展 实时图像采集与显示软件。具体目标2：先导临床研究。使用拟议的 SLO系统将与目前的商业替代方案进行比较，比较非接触模式和非接触模式 接触式眼底相机，以及使用宽视场SLO和接触式宽视场眼底相机的接触模式。 这项提议的预期结果是开发和初步验证儿科专用SLO 该系统将构成未来临床验证和最终商业化努力的基础。

项目成果

Hybrid spiral scanning in a double-clad fiber-based handheld confocal scanning light ophthalmoscope.

基于双包层光纤的手持式共焦扫描光检眼镜中的混合螺旋扫描。

• DOI: 10.1364/boe.500608
• 发表时间: 2023
• 期刊: Biomedical optics express
• 影响因子: 3.4
• 作者: Wei,Franklin;Hagan,Kristen;Viehland,Christian;Tao,YuankaiK;Kuo,AnthonyN;Izatt,JosephA;Dhalla,Al-Hafeez
• 通讯作者: Dhalla,Al-Hafeez