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

摘要 该项目将为脑震荡的视觉亚型创建第一个客观测量工具VisBox (VSC)。这将使医生能够在没有眼睛护理专业人员的情况下识别VSC，以便转介到视力 提供个性化视力治疗建议的专家。 脑震荡症状持续数周以上通常会改变患者的生活。 个人和儿童尤其脆弱，因为他们有患慢性疼痛等共病的风险， 疲劳、抑郁、焦虑和学习困难。缺乏可获得的、客观的视力诊断 识别VSC和转诊治疗的关键障碍。VisBox将是一款软件产品， 与Oculogica专有的眼睛跟踪硬件平台OcuTracker配合使用。VisBox将输入Eyes 来自OcuTracker的运动测量，计算对应于脑神经的各个方面的指标 脑震荡期间受影响的功能，并使用这些指标来计算分数，以使用 在本研究过程中，开发了基于引导式机器学习的算法。VisBox将由非 视力专家客观测量与脑震荡有关的三种视力障碍：会聚 在4分钟内出现功能不全(CI)、调节功能不全(AI)和眼球跳动功能障碍(SD) 被诊断为脑震荡的临床访问。长期目标是制定一项客观的评估 视力特征，这将使非视力专家的医生能够1)筛查 脑震荡相关的视力障碍；2)确定VSC；3)决定是否有必要转诊为 综合视力检查；4)监测视力治疗效果。 第一阶段假设。VisBox可以产生与存在或不存在TBI相关的输出分数- 通过利用OcuTracker视觉刺激和眼球跟踪系统，可以获得与视力障碍相关的视觉障碍，即VSC。 具体目标1.生成OcuTracker眼球跟踪数据和250年脑外伤相关视力障碍的诊断 儿童脑震荡患者。 使用OcuTracker数据开发和验证VisBox算法，用于评估CI、AI和SD。 第二阶段的计划。VisBox评分将被用来预测未来视力治疗的反应性 随机临床研究。第二阶段将是一项多臂研究，比较视力疗法和安慰剂疗法。 并评估VisBox软件是否可以预测哪些患者有反应 为了视觉治疗。 商机。VisBox的客户是包括神经科医生在内的非眼科护理专家， 儿科医生、急诊室医生、运动医学医生和脑震荡专家。总数 潜在市场为4亿美元，假设美国脑震荡所需的每年扫描400万次，每次扫描100美元。

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.