The nGoggle: A portable brain-based device for assessment of visual function deficits

项目摘要 评估中心凹区域以外的视功能丧失是治疗的重要组成部分 许多疾病，包括青光眼、视网膜和神经系统疾病。尽管取得了重大进展， 随着几十年前标准自动视野检查（SAP）的发展， SAP的场损耗仍然具有显著的缺点。SAP测试受到患者反应主观性的限制， 高的重测变异性，经常需要许多测试来有效检测随时间的变化。此外，委员会认为， 由于这些测试通常在基于诊所的环境中进行，有限的患者可用性和卫生保健 资源往往导致随着时间的推移获得的测试数量不足，诊断和检测延迟 疾病的发展。对训练有素的技术人员的要求、成本、复杂性和缺乏便携性 也排除了其用于在服务不足的人群中筛查视野丧失。解决 针对目前评估视觉功能的方法的缺点，我们开发了nGoggle，一种可穿戴设备， 该设备使用集成了无线脑电图（EEG）的头戴式显示器（HMD），能够 使用多焦稳态视觉诱发电位（mfSSVEP）客观评估视野缺损。在 在我们的NEI SBIR第一阶段项目中，我们使用改进的基于智能手机的头戴式显示器开发了nGoggle原型 显示器和非一次性电极。我们还对EEG信号质量进行了基准测试 采集，开发了EEG数据提取和分析方法，并进行了试点研究，证明 该装置检测青光眼视野丧失的能力。根据第一阶段令人鼓舞的结果， 并清楚地描述了将该设备转化为最终商业产品所需的步骤，我们继续 进行NEI STTR第二阶段研究，具体目标是：1）开发定制的头戴式显示器 和增强的无准备电极，用于提高nGoggle在高信号下获取用户mfSSVEP的能力， 2）优化和验证mfSSVEP刺激设计， 数据分析，以提高nGoggle评估视觉功能丧失的准确性和可重复性; 3） 完成关键临床研究以支持FDA批准。由于在扩大他们的领域方面缺乏进展 在使用反射光波的市售头戴式近眼显示器中， 指南（ROW），我们需要开发一个定制的近眼显示器（NED），所需的FOV为60°对角线 使用微AMOLED面板和自由形式表面（FFS）反射器。本行政补充 研究将为一个为期六个月的子项目提供必要的资金，以开发定制的近视眼 显示器和软件图像补偿以对抗扩展视场中的光学失真。的 技术将用于实现我们的第二阶段项目的具体目标，并使nGoggle为 商业化生产。

PROJECT SUMMARY Assessment of visual function loss outside the foveal area is an essential component of the management of numerous conditions, including glaucoma, retinal and neurological disorders. Despite the significant progress achieved with the development of standard automated perimetry (SAP) many decades ago, assessment of visual field loss with SAP still has significant drawbacks. SAP testing is limited by subjectivity of patient responses and high test-retest variability, frequently requiring many tests for effective detection of change over time. Moreover, as these tests are generally conducted in clinic-based settings, limited patient availability and health care resources often result in an insufficient number of tests acquired over time, with delayed diagnosis and detection of disease progression. The requirement for highly trained technicians, cost, complexity, and lack of portability of SAP also preclude its use for screening of visual field loss in underserved populations. To address shortcomings of current methods to assess visual function, we have developed the nGoggle, a wearable device that uses a head-mounted display (HMD) integrated with wireless electroencephalography (EEG), capable of objectively assessing visual field deficits using multifocal steady-state visual-evoked potentials (mfSSVEP). In our NEI SBIR Phase I project, we developed the nGoggle prototype using a modified smartphone-based HMD display and non-disposable electrodes. We also conducted benchmarking tests on signal quality of EEG acquisition, developed methods for EEG data extraction and analysis, and conducted a pilot study demonstrating the ability of the device to detect visual field loss in glaucoma. Based on the encouraging results from Phase I and a clear delineation of the steps needed to bring the device into a final commercial product, we proceeded to conduct the NEI STTR Phase II studies with the specific aims: 1) to develop a customized head-mounted display and enhanced no-prep electrodes for improving nGoggle’s ability to acquire users’ mfSSVEP with high signal- to-noise ratios (SNR) in response to visual stimulation; 2) to optimize and validate mfSSVEP stimuli design and data analytics to enhance the accuracy and repeatability of assessing visual function loss with the nGoggle; 3) to complete pivotal clinical studies to support FDA approval. Due to the lack of progress in expanding their field of view (FOV) among the commercially available head-mounted near-eye displays using reflective optical wave- guides (ROW), we need to develop a customized near eye display (NED) with the required FOV of 60° diagonal using a micro-AMOLED panel and a Free Form Surface (FFS) reflector. This Administrative Supplement for Research will provide the necessary funding for a six-month sub-project to develop the customized near eye display and the software image compensation against the optical distortion in the expanded field of view. The technology will then be used to achieve the specific aims of our Phase II project and get the nGoggle ready for commercial production.