Portable In vivo Confocal Ophthalmoscope (PICO) for Accurate and Rapid Diagnosis of Corneal Ulcer

便携式体内共焦检眼镜 (PICO) 可准确快速诊断角膜溃疡

• 批准号: 10339950
• 负责人: Dongkyun Kang
• 金额: $ 36.03万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10339950
• 关键词: Acanthamoeba; Address; Adoption; Agreement; Animals; Arizona; Blindness; Cattle; Cellular Phone; Clinic Visits; Clinical; Collaborations; Consumption; Cornea; Corneal Diseases; Corneal Ulcer; Custom; Data; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic Sensitivity; Dry Eye Syndromes; Early Diagnosis; Endothelium; Engineering; Epidemic; Equipment; Evaluation; Family suidae; Goals; Gold; Histology; Hospitals; Image; Imaging Device; Imaging Techniques; Infection; Lasers; Light; Methods; Microbiology; Modeling; Monitor; Nerve; Ophthalmologist; Ophthalmology; Ophthalmoscopes; Ophthalmoscopy; Optics; Organism; Outcome; Parasites; Parkinson Disease; Patients; Perforation; Performance; Peripheral Nervous System Diseases; Persons; Prospective Studies; Rapid diagnostics; Reference Standards; Reporting; Research; Resolution; Resources; Risk; Scanning; Sensitivity and Specificity; Skin; Source; Specificity; Speed; Strategic Planning; Technology; Test Result; Testing; Time; Tissues; Uganda; Ulcer; Universities; Visual; Visual impairment; accurate diagnosis; accurate diagnostics; base; case-based; cellular imaging; clinical diagnosis; clinical examination; cost; diagnostic accuracy; diagnostic strategy; experience; eye dryness; fungus; health care settings; high resolution imaging; human imaging; imaging approach; in vivo; innovation; lens; microscopic imaging; novel strategies; portability; prevent; prototype; rapid diagnosis; reflectance confocal microscopy; sensor; skin lesion

Project Summary/Abstract Corneal ulcers caused by infection are causing blindness and visual impairment in 4.2 million people worldwide annually and have been described as a “silent epidemic”. Corneal ulcers can be caused by several different organisms, with those caused by fungi or Acanthamoeba parasites often associated with the worst outcomes. Accurate and rapid diagnosis of the causative organism can prevent tissue damage leading to blindness. But clinical outcomes are often poor because the first-line diagnostic method, slit lamp examination, is often inaccurate, and the gold standard diagnostic method, microbiological testing, is time-consuming, prone to false negatives, and resource-intensive. We aim to develop a Portable In vivo Confocal Ophthalmoscope (PICO) that can provide accurate and rapid diagnosis in corneal ulcers. We have established a research team of leading ophthalmology and optical engineering experts to achieve this goal: In vivo confocal microscopy (IVCM) is the only clinically- available imaging tool that can directly visualize causative organisms in the patient’s cornea. Dr. Jaya Chidambaram (Co-I, University of Manchester, UK) led the first prospective study to test laser-scanning IVCM in fungal and Acanthamoeba ulcer patients, which established high diagnostic sensitivity (86-88%) and specificity (81-98%). Further studies by others demonstrated similarly high diagnostic accuracy. But widespread adoption of IVCM has been hampered by the following weaknesses: 1) contact imaging, 2) limited field of view (FOV) and speed, and 3) high device cost (>$75,000). While searching for a new approach to overcome these weaknesses, Dr. Chidambaram began a collaboration with Dr. Dongkyun Kang (PI, University of Arizona) in 2019. Dr. Kang’s team previously invented the world’s first smartphone-based, portable IVCM device (cost = ~ $4,000), successfully imaged skin lesions from >350 patients in Uganda, and demonstrated imaging of cellular details of the cornea with similar image quality to the commercial IVCM. In this 3-year R01 project, we will further innovate our skin portable IVCM technology to develop a PICO device that (1) enables non-contact corneal imaging, (2) increases the FOV 12 times and speed 8 times, and (3) reduces the device cost >10 times compared to the commercial corneal IVCM device. We will develop a PICO prototype (Aim 1) and evaluate for corneal ulcer (fungal subtype) ex vivo (Aim 2). We envision that PICO will become a standard corneal imaging tool worldwide, and will make significant impacts on diagnosis and treatment monitoring of corneal ulcers and other major corneal diseases, including dry eye disease, Fuch’s endothelial dystrophy, and corneal nerve evaluation to screen for peripheral neuropathy in Parkinson’s disease and diabetes mellitus. Our proposal directly addresses several unmet needs identified in the NEI’s strategic plan, including high-resolution imaging techniques to diagnose common corneal disorders, and methods for early detection of corneal disease epidemics.

项目摘要/摘要 由感染引起的角膜溃疡会导致420万人的失明和视力障碍 每年在全球范围内，被描述为“沉默的流行病”。角膜溃疡可能是由几个 不同的生物是由真菌或阿斯塔莫巴寄生虫引起的生物 结果。对病因的准确和快速诊断可以防止组织损伤 失明。但是临床结果通常很差，因为一​​线诊断方法，缝隙灯检查， 通常是不准确的，金标准诊断方法，微生物测试，很耗时，容易发生 虚假负面和资源密集型。 我们旨在开发一种可以提供准确和准确的体内共聚焦眼镜（PICO） 角膜溃疡的快速诊断。我们已经建立了一个领先的眼科研究团队 实现此目标的光学工程专家：体内共聚焦显微镜（IVCM）是唯一的临床 - 可直接可视化患者角膜中警告性生物的可用成像工具。 Jaya博士 Chidambaram（英国曼彻斯特大学CO-I）领导了第一项前瞻性研究，以测试激光扫描IVCM 在真菌和阿斯塔amoeba溃疡患者中，建立了高诊断敏感性（86-88％）和 特异性（81-98％）。其他人的进一步研究表明，诊断准确性类似。但 宽度采用IVCM已受到以下弱点的阻碍：1）接触成像，2）限制 视场（FOV）和速度和3）高设备成本（> $ 75,000）。在寻找一种新方法的同时 克服了这些弱点，Chidambaram博士开始与Dongkyun Kang博士合作（PI， 亚利桑那大学）。康博士的团队以前发明了世界上第一个基于智能手机 便携式IVCM设备（成本=〜$ 4,000），在乌干达> 350例患者中成功成像的皮肤病变和 证明了角膜的细胞细节的成像，其图像质量与商业IVCM相似。 在这个为期3年的R01项目中，我们将进一步创新我们的皮肤便携式IVCM技术，以开发一个 （1）启用非接触角膜成像的PICO设备，（2）增加了FOV 12次，速度8 时间，（3）与商业角膜IVCM设备相比，设备的成本> 10倍。我们将 开发PICO原型（AIM 1），并评估角膜溃疡（真菌亚型）外体（AIM 2）。 我们设想PICO将成为全球标准的角膜成像工具，并将变得重要 对角膜溃疡和其他主要角膜疾病的诊断和治疗监测的影响，包括 干眼症，fuch的内皮营养不良和角膜神经评估以进行周围 帕金森氏病和糖尿病的神经病。我们的建议直接解决了几个未满足的 NEI的战略计划中确定的需求，包括诊断常见的高分辨率成像技术 角膜疾病和早期检测角膜疾病流行病的方法。