STTR Phase II: A novel retinal imaging device

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是帮助促进视网膜和神经系统疾病患者的健康和福利。这包括多发性硬化症（MS）-一种使人衰弱的自身免疫性疾病，影响美国近100万人。将开发一种全自动、可穿戴、低成本的视网膜成像设备，用于临床和家庭环境，检测视网膜的变化，使患者及其医生能够更常规地跟踪治疗效果和眼部副作用。MS的早期发现和治疗对于降低疾病进展和残疾的风险至关重要。目前的做法依赖于不频繁的神经和放射学检查，以评估疾病活动和治疗效果的变化。然而，目前没有办法在这些访问之间真实的时间监测MS。将视网膜病理学与大脑中的MS过程相关的研究表明，视网膜成像可以提供疾病事件的早期检测，提供替代的监测途径。因此，该设备将有助于降低与日益增加的残疾相关的患者医疗费用，并积极影响其他视网膜疾病的研究和护理，包括年龄相关性黄斑变性（AMD）和特发性颅内高压（IIH）。该小型企业创新研究（SBIR）二期项目将产生一种新型视网膜成像设备，该设备使用光学相干断层扫描（OCT）评估视网膜病理。虽然OCT是一种广泛使用的视网膜成像方式，但所提出的设备与当前技术的区别在于，它是专门为患者在家中无监督使用而设计的。这包括坚固耐用和符合人体工程学的设计，适合那些患有低视力，低流动性和其他症状，使频繁前往诊所困难的人。患者将根据医生的处方使用该设备，在此期间，视网膜图像将被自动采集、分析并发送给医生进行远程审查。因此，它将通过使患者更积极地参与疾病管理来进一步增加患者和医生之间的参与。该项目计划实现以下目标：1）完成适用于临床和家庭环境的临床级beta原型的开发，2）开发用于自动化图像分析和报告的软件管道，和3）在不同程度视力丧失的AMD患者队列中进行可用性研究。该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识价值和更广泛的影响审查标准进行评估。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to help advance the health and welfare of individuals living with retinal and neurological disease. This includes multiple sclerosis (MS)—a debilitating autoimmune disease affecting nearly 1 million people in the United States. A fully automated, wearable, and low-cost retinal imaging device will be developed for use in both clinical and home settings that detects changes in the retina, allowing patients and their physicians to more routinely track treatment efficacy and ocular side effects. Early detection and treatment of MS is crucial to reducing the risk of disease progression and disability. Current practice relies on infrequent neurological and radiological exams to assess changes in disease activity and treatment efficacy. However, there is currently no way to monitor MS in real time between these visits. Research relating retinal pathology to MS processes in the brain demonstrate that retinal imaging can provide early detection of disease events, offering an alternative monitoring pathway. This device will thus help reduce patient healthcare costs associated with increasing disability, and positively impact the research and care of other retinal diseases, including age-related macular degeneration (AMD) and idiopathic intracranial hypertension (IIH).This Small Business Innovation Research (SBIR) Phase II project will yield a novel retinal imaging device that uses optical coherence tomography (OCT) to assess retinal pathology. While OCT is a widely-used modality for imaging the retina, the proposed device differentiates itself from current technologies in that it is specifically designed for unsupervised use by patients at home. This includes a ruggedized and ergonomic design suited for those who suffer from low vision, low mobility, and other symptoms that make frequent trips to a clinic difficult. Patients will use the device briefly as often as prescribed by their doctor, during which time retinal images will be automatically acquired, analyzed, and sent to a physician for remote review. As such, it will further increase engagement between patients and physicians by making patients more proactively involved in their disease management. For this project, the following objectives are planned: 1) Complete development of a clinical-grade beta prototype that is suitable for use in clinical and home settings, 2) Develop a software pipeline for automated image analysis and report, and 3) Conduct a usability study in a cohort of AMD patients with varying degrees of vision loss.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.