Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

婴幼儿无法就视力丧失或障碍进行沟通， 在不可逆转的视力丧失发生之前诊断威胁视力的疾病。市售儿科 视网膜成像技术，包括手持OCT（HH-OCT）和手持眼底照相机，可用于 筛查和诊断这些年轻患者的眼病;然而，这些技术具有重要意义， 这些缺点诸如差的可用性、高成本和/或引起显著的患者不适和压力。一 儿科视网膜成像的重要应用是早产儿视网膜病变的筛查 （ROP）。HHOCT的发展显著提高了我们对ROP进展的理解， 但是其作为ROP的诊断工具的使用受到商业上的高成本和差的可用性的限制。 系统.类似地，当前可用的宽视场彩色眼底相机过于昂贵，并且可能会被损坏。 由于使用接触透镜和明亮的照明闪光而引起的应力。与使用相关的压力 这些设备可能使重复成像复杂化，因为年幼的儿童迅速发育并且对这些设备产生厌恶反应。 设备.此外，反复暴露于压力已被证明会影响早产儿的神经发育。 婴儿。因此，用这些类型的系统中的任一种捕获婴儿和幼儿的图像是昂贵的， 具有挑战性，需要经过大量培训的专业研究人员。显然，需要降低- 成本低，易于使用的儿科视网膜成像系统，理想的是不会给早产儿造成压力。 这项探索性/发展性研究补助金提案汇集了一个工程师和临床医生团队- 具有眼科成像技术开发和翻译专业知识的科学家， 特定的手持式扫描激光检眼镜（SLO），以解决当前商业上 可用的小儿视网膜成像设备。这项技术将大大提高护理标准， 婴儿和幼儿目前得不到现有技术的服务。为了解决这一未满足的临床 需要，我们建议构建一个原型，儿科专用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、宽视场SLO系统， 人体工学手持式探头。该器械将在两种模式下运行;非接触模式提供60° FOV 和18 µm分辨率，最高可达每秒10帧，接触模式采用市售 单次使用的隐形眼镜，提供120° FOV和44 µm分辨率，也高达10 fps。我们还将开发 实时图像采集和显示软件。具体目标2：初步临床研究。使用所提出的 SLO系统将与当前的商业替代品进行比较，将非接触模式与非接触模式进行比较， 接触式眼底照相机，以及具有宽视场SLO和接触式宽视场眼底照相机的接触模式。 该提案的预期结果是开发和初步验证儿科专用SLO 该系统将成为未来临床验证和最终商业化的基础。

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.