STTR Phase II: A novel retinal imaging device

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.