smartOCT: a low-cost technology to detect and monitor glaucoma in outpatient and primary care centers

smartOCT：一种在门诊和初级保健中心检测和监测青光眼的低成本技术

基本信息

批准号：
10579902
负责人：
Audrey Kynsella Bowden
金额：
$ 39.07万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10579902
关键词：
Adult Affect Agreement Algorithmic Software Ambulatory Care Appointment Blindness Caring Cellular Phone Clinic Clinical Clinical Research Communities Data Democracy Detection Deterioration Devices Diabetes Mellitus Diagnosis Disease Early treatment Effectiveness Endocrinology Ethnic Origin Evaluation Eye Family Glaucoma Health Health Fairs Image Imaging Techniques Improve Access Insurance Laboratories Latino Lie Detection Manuals Measurement Measures Modeling Monitor Morphologic artifacts Motion Nature Ophthalmologist Ophthalmology Optic Disk Optic Nerve Optical Coherence Tomography Outcome Outpatients Patients Performance Peripheral Persons Pharmacy facility Physiologic Intraocular Pressure Pilot Projects Population Study Prevalence Primary Care Primary Open Angle Glaucoma Qualitative Methods Qualitative Research Recording of previous events Research Resources Risk Risk Factors Role Scanning Services Signal Transduction Site System Technology Telemedicine Thick Time Training Travel Underserved Population Vision Visualization Work aged cost cost effective experience glaucoma test global health health care quality health care settings healthy volunteer high resolution imaging high risk imaging system innovation instrument light weight modifiable risk new technology novel optical disc outpatient programs point of care portability preservation primary care clinic primary care provider programs prototype retinal imaging retinal nerve fiber layer screening screening program sensor smartphone based device stem telehealth user-friendly

项目摘要

ABSTRACT: Glaucoma is the leading cause of irreversible vision loss globally. Nearly 52.7 million people will be affected in 2020, and that number will grow to ~79.8 million by 2040. The prevalence varies by ethnicity, and the rates of undiagnosed primary open angle glaucoma are alarmingly high (50-85%) in white, black and Latino patients. The challenge in glaucoma detection lies in the asymptomatic nature of its early stage: damage to the optic nerve occurs in an unnoticeable manner that slowly deteriorates the peripheral vision. By the time many patients seek evaluation, the disease has reached a late stage and it is a challenge to preserve the limited remaining central vision. Importantly, early treatment to decrease intraocular pressure (IOP), the only modifiable risk factor for glaucoma, can reduce the rate of progression by 50%, but large population- based studies have confirmed that screening based on IOP is clinically ineffective. Optical coherence tomography (OCT) is central technology for glaucoma screening in standard ophthalmology services. However, the cost and size of clinical OCT systems limits access to the technology by underserved populations, who are simultaneously more likely to be affected with glaucoma-inducing conditions (e.g., diabetes) and less likely to have access to adequate eye care, vision insurance and ability to travel for additional appointments. The availability of low-cost, portable and user-friendly technologies that are deployable in non-specialist outpatient settings (e.g., primary care clinics, endocrinology offices) where high-risk patients present most often is a critical barrier to widespread implementation of effective glaucoma screening programs. We propose a new paradigm for OCT imaging – smartOCT – that leverages the small form factor and ubiquity of smartphones (SPs) to yield a low-cost, lightweight, small-footprint device that facilitates capture, processing, visualization and interpretation of OCT data in outpatient services. Our innovative strategy targets comprehensive integration of OCT with the built-in sensors of smartphones to lower the critical barriers to mass deployment of OCT in clinics. We will demonstrate the feasibility of this technology and clinical workflow through the following specific aims: Aim 1) Finalize a smartOCT prototype for low-cost optic nerve imaging. Aim 2) Confirm the repeatability of smartOCT and comparison to conventional OCT in a pilot clinical study (n = 60). Aim 3) Evaluate the preliminary effectiveness for outpatient services in a pilot study (n = 40) with primary care. If successful, our work will suggest a clear path to broaden access to the OCT technology needed to detect glaucoma and to inspire equip new paradigms and contexts for effective glaucoma screening (e.g., clinics, health fairs, telemedicine). Successful implementation of smartOCT technology will also blaze a trail for the OCT research community to consider new form factors and new scanning mechanisms that can be implicated to study other clinical diseases and/or used in other resource-limited contexts (e.g., global health).

摘要：青光眼是全球近 5270 万人不可逆转视力丧失的主要原因。到 2020 年将受到影响，到 2040 年这一数字将增至约 7980 万。患病率因种族而异，在白人、黑人和白人中，未确诊的原发性开角型青光眼的比率高得惊人（50-85%）。拉丁裔患者检测青光眼的挑战在于其早期阶段的无症状性质：视神经以不明显的方式发生损伤，慢慢地使周边视力恶化。当许多患者寻求评估时，疾病已达到晚期，保留是一个挑战重要的是，早期治疗以降低眼压（IOP）。唯一可改变的青光眼危险因素，可将进展率降低 50%，但大量人群- 基础研究证实，基于眼压的筛查在临床上是无效的。光学相干断层扫描 (OCT) 是标准眼科青光眼筛查的核心技术然而，临床 OCT 系统的成本和规模限制了服务不足的人获得该技术的机会。同时更有可能受到青光眼诱发疾病影响的人群（例如，糖尿病），并且不太可能获得足够的眼部护理、视力保险和旅行能力额外的预约。可部署在非专科门诊环境（例如初级保健诊所、内分泌科办公室）高危患者最常出现的地方是广泛实施有效的青光眼筛查计划。我们提出了一种新的 OCT 成像范例——smartOCT——它利用了小尺寸和普遍性智能手机（SP），以产生低成本、轻量级、小占用空间的设备，有利于捕获、处理、我们的创新战略目标是门诊服务中 OCT 数据的可视化和解释。 OCT与智能手机内置传感器的全面集成，降低了关键壁垒我们将展示该技术和临床工作流程的可行性。通过以下具体目标：目标 1) 完成用于低成本视神经成像的 smartOCT 原型。目标 2) 在试点临床研究中确认 smartOCT 的可重复性并与传统 OCT 进行比较 (n = 60) 目标 3) 评估初步研究中门诊服务的有效性（n = 40）。如果成功，我们的工作将为扩大 OCT 技术的获取提供一条清晰的道路。检测青光眼并激发装备新的范例和环境以进行有效的青光眼筛查（例如， smartOCT 技术的成功实施也将为以下领域开辟道路。 OCT 研究界考虑新的外形尺寸和新的扫描机制涉及研究其他临床疾病和/或用于其他资源有限的环境（例如全球健康）。