SBIR-STTR Award

This project will create the first objective measurement tool, the VisBox, for the vision subtype of concussion (VSC). This will enable physicians to identify VSC without an eye-care professional, for referral to a vision specialist for personalized vision therapy recommendations. The persistence of concussion symptoms beyond several weeks is often a life-altering situation for affected individuals, and children are particularly vulnerable as they are at risk for co-morbidities such as chronic pain, fatigue, depression, anxiety, and learning difficulties. A lack of accessible, objective vision diagnostics are critical barriers to identification of VSC and referral for treatment. The VisBox will be a software product that is used with the OcuTracker, Oculogica’s proprietary eye-tracking hardware platform. The VisBox will input eye movement measurements from the OcuTracker, calculate metrics that correspond to aspects of cranial nerve function affected during a concussion, and use those metrics to calculate a score to predict VSC using an algorithm developed with guided machine learning in the course of this study. The VisBox will be used by non- vision specialists to objectively measure three vision disorders related to concussion: convergence insufficiency (CI), accommodative insufficiency (AI), and saccadic dysfunction (SD) in under 4 minutes, during the clinical visit where the concussion is diagnosed. The long-term goal is to develop an objective assessment of vision characteristics, that will enable physicians that are non-specialists in vision to 1) screen for concussion-related vision disorders; 2) identify VSC; 3) make decisions about the necessity of a referral for a comprehensive vision examination; 4) monitor the effectiveness of vision treatment. Phase I Hypothesis. VisBox can produce an output score that correlates with the presence or absence of TBI- related vision disorder, i.e., VSC, by leveraging the OcuTracker visual stimulus and eye tracking system. Specific Aim I. Generate OcuTracker eye tracking data and the diagnosis of TBI-related vision disorder in 250 pediatric concussion patients. Specific Aim II. Develop and validate VisBox algorithm for assessing CI, AI, and SD using OcuTracker data. Plans for Phase II. The VisBox score will be used to predict responsiveness to vision therapy in a prospective randomized clinical study. Phase II will be a multi-armed study comparing vision therapy with placebo therapy in concussion patients and assessing whether the VisBox software can predict which patients are responsive to vision therapy. Commercial Opportunity. VisBox customers are non-eye care specialists including neurologists, pediatricians, emergency room physicians, sports medicine physicians, and concussion specialists. The total addressable market is $400M, assuming 4M annual scans at $100/scan needed for concussions in the US.

Public Health Relevance Statement:
PUBLIC HEALTH RELEVANCE STATEMENT At least 4 million concussions occur in the US each year, and up to 30% of these injuries persist beyond 4 weeks in a condition known as persistent post-concussion symptoms, which is often a life-altering situation for affected individuals, with children particularly vulnerable as they are at risk for co-morbidities such as chronic pain, fatigue, depression, anxiety, and learning difficulties – with often serious consequences. The lack of an accessible, objective vision diagnostics presents a critical barrier to identification of the vision disorder concussion sub-type (VSC) and referral for treatment. The proposed technology will be the first objective tool that can be used by non-vision-specialists to identify concussion-related vision symptoms that is accessible to a broad range of facilities and will enable non-specialist physicians the ability to refer patients to concussion specialists to improve outcomes, decrease the time it takes patients to return to work or play, and reduce healthcare costs associated with this debilitating condition.

Project Terms:
Address; Affect; Algorithms; Anxiety; Area Under Curve; associated symptom; Brain Concussion; Caring; Characteristics; Child; Childhood; chronic pain; Clinical; Clinical assessments; Clinical Research; commercial application; Comorbidity; Computer software; concussive symptom; Convergence Insufficiency; Cranial Nerves; Data; Data Analyses; Decision Making; Devices; Diagnosis; Diagnostic; disabling symptom; disorder subtype; economic impact; Economics; Effectiveness; Emergency Department Physician; Evaluation; Eye; Eye Movements; Family; Fatigue; Fees; Functional disorder; Goals; handheld equipment; Health Care Costs; improved outcome; Individual; Injury; Intervention; Learning; lens; Life; Machine Learning; Measurement; Measures; Mental Depression; Monitor; Neurologist; Neurosurgeon; novel; Optometrist; Output; Patients; pediatrician; Performance; Phase; Physicians; Placebos; Play; population based; Post-Concussion Syndrome; Prevalence; Primary Care Physician; prospective; public health relevance; Randomized; Recommendation; recruit; Research Personnel; Resolution; Rest; Risk; Sampling; Scanning; skills; Small Business Technology Transfer Research; software development; Software Tools; Specialist; Sports Medicine; success; Symptoms; System; TBI Patients; Technology; Therapeutic Intervention; therapy outcome; Time; tool; Traumatic Brain Injury recovery; Treatment Efficacy; tv watching; Vision; Vision Disorders; Visit; visual stimulus; Work