A software tool for objective identification of concussion-related vision disorders using a novel eye-tracking device

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ABSTRACT 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.