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.

项目概要/摘要 感染引起的角膜溃疡导致 420 万人失明和视力障碍 角膜溃疡在世界范围内被称为“无声的流行病”，可由多种原因引起。 不同的生物体，其中由真菌或棘阿米巴寄生虫引起的生物体通常与最糟糕的情况有关 准确、快速地诊断致病微生物可以防止导致组织损伤。 但临床结果往往很差，因为一​​线诊断方法，裂隙灯检查， 往往不准确，而金标准诊断方法微生物检测既耗时又容易出现问题 误报和资源密集型。 我们的目标是开发一种便携式体内共焦检眼镜（PICO），它可以提供准确和 我们建立了领先的眼科和角膜溃疡快速诊断团队。 光学工程专家实现这一目标：体内共聚焦显微镜（IVCM）是唯一的临床- Jaya 博士表示，可用的成像工具可以直接观察患者角膜中的致病微生物。 Chidambaram（英国曼彻斯特大学 Co-I）领导了第一项测试激光扫描 IVCM 的前瞻性研究 在真菌和棘阿米巴溃疡患者中，建立了高诊断敏感性 (86-88%) 和 其他人的进一步研究证明了同样高的诊断准确性。 IVCM 的广泛采用受到以下缺点的阻碍：1) 接触式成像，2) 有限 视场 (FOV) 和速度，以及 3) 高设备成本（> 75,000 美元）。 为了克服这些弱点，Chidambaram 博士开始与 Dongkyun Kang 博士（PI、 亚利桑那大学）于2019年。康博士的团队此前发明了世界上第一个基于智能手机的、 便携式 IVCM 设备（成本 = ~ 4,000 美元），成功对乌干达超过 350 名患者的皮肤病变进行成像，以及 角膜细胞细节成像，具有与商业 IVCM 类似的图像质量。 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，开发一种 PICO 设备 (1) 可实现非接触式角膜成像，(2) 将视场提高 12 倍，速度提高 8 与商业角膜 IVCM 设备相比，（3 降低）设备成本 >10 倍。 开发 PICO 原型（目标 1）并评估离体角膜溃疡（真菌亚型）（目标 2）。 我们预计 PICO 将成为全球标准的角膜成像工具，并将产生重大影响 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 干眼病、富赫氏内皮营养不良症和角膜神经评估以筛查外周疾病 我们的建议直接解决了一些未得到满足的问题。 NEI 战略计划中确定的需求，包括诊断常见疾病的高分辨率成像技术 角膜疾病，以及早期检测角膜疾病流行的方法。