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

摘要：青光眼是全球不可逆性视力丧失的主要原因。近5270万人将 2020年受到影响，到2040年，这一数字将增长到7980万。患病率因种族而异， 在白人、黑人和黑人中，未确诊的原发性开角型青光眼的比率高得惊人(50%-85%) 拉丁裔病人。青光眼检测的挑战在于其早期阶段的无症状性质： 视神经的损害是以一种不明显的方式发生的，它会慢慢地恶化周围的视力。通过 在许多患者寻求评估的时候，这种疾病已经到了晚期，保存起来是一个挑战 剩下的有限的中心视力。重要的是，早期治疗以降低眼压， 只有青光眼的可修改危险因素才能将进展率降低50%，但大量人口- 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 服务。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 人群，他们同时更有可能受到青光眼诱发条件的影响(例如， 糖尿病)，不太可能获得适当的眼睛护理、视力保险和旅行能力 其他约会。低成本、便携和用户友好的技术的可用性 可在非专科门诊环境中部署(例如，初级保健诊所、内分泌办公室) 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成像模式--SmartOCT，它利用了小巧的外形和无处不在的特性 智能手机(SP)，以产生低成本、轻便、占用空间小的设备， 门诊OCT数据的可视化和解释。我们的创新战略目标 OCT与智能手机内置传感器的全面集成，降低了 OCT在临床上的大规模部署。我们将论证这项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。 目的2)在一项初步的临床研究中，确认SmartOCT的可重复性，并与传统OCT进行比较。 60)。目的3)在一项初步研究(n=40)中评估门诊服务的初步效果 关心。如果成功，我们的工作将提出一条明确的途径，扩大获得OCT技术所需的途径 检测青光眼并为有效的青光眼筛查装备新的范例和背景(例如， 诊所、健康博览会、远程医疗)。SmartOCT技术的成功实施也将为 OCT研究社区考虑新的外形因素和新的扫描机制，可以 涉及研究其他临床疾病和/或在其他资源有限的情况下使用(例如，全球卫生)。

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).