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视力丧失的主要原因。近5270万人将 到2020年，这一数字将增长到约7980万。患病率因种族而异， 未诊断的原发性开角型青光眼的比率在白色、黑人和 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： 视神经的损伤以不明显的方式发生，其缓慢地恶化周边视觉。通过 当许多患者寻求评估时，疾病已经到了晚期， 有限的中央视觉。重要的是，早期治疗以降低眼内压（IOP）， 青光眼的唯一可改变的危险因素，可以减少50%的进展率，但大的人群- 基于IOP的研究已经证实，基于IOP的筛查在临床上是无效的。 光学相干断层扫描（OCT）是标准眼科学中青光眼筛查的核心技术 服务然而，临床OCT系统的成本和尺寸限制了服务不足者对该技术的使用。 人群，他们同时更有可能受到脑卒中诱导条件的影响（例如， 糖尿病），更不可能获得足够的眼科护理，视力保险和旅行能力， 额外的任命。提供低成本、便携式和方便用户的技术， 可部署在非专科门诊设置中（例如，初级保健诊所、内分泌科诊所） 高风险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 -它利用了小尺寸和普遍存在的 智能手机（SP）的生产成本低，重量轻，占地面积小的设备，便于捕获，处理， 门诊服务中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，以降低 OCT在诊所的大规模部署。我们将证明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）最终确定用于低成本视神经成像的smartOCT原型。 目的2）在初步临床研究中确认smartOCT的可重复性以及与传统OCT的比较（n = 10）。 60）。目的3）在一项初步研究（n = 40）中评价门诊服务的初步有效性， 在乎如果成功的话，我们的工作将为扩大OCT技术的使用提供一条清晰的道路， 检测青光眼并激发装备用于有效青光眼筛查的新范例和背景（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研究界考虑新的形式因素和新的扫描机制， 涉及研究其它临床疾病和/或用于其它资源有限的环境（例如，全球健康）。

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).