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

项目总结 黄斑中心凹区域外视功能丧失的评估是黄斑中心凹治疗的重要组成部分。 多种疾病，包括青光眼、视网膜和神经疾病。尽管取得了重大进展 几十年前随着标准自动视野检查(SAP)的发展而实现，视觉评估 与SAP的现场损失仍有明显的缺点。SAP测试受到患者反应的主观性和 重测变异性高，经常需要多次测试才能有效检测随时间变化的情况。此外， 由于这些测试通常是在诊所环境中进行的，患者的可获得性和医疗保健有限 资源往往导致随着时间的推移而获得的检测数量不足，从而导致诊断和检测的延迟 疾病的进展。对训练有素的技术人员的要求、成本、复杂性以及缺乏可移植性 SAP的使用也排除了将其用于筛查服务不足人群的视野丧失。致信地址 针对目前视觉功能评估方法的不足，我们开发了可穿戴设备nGogle 它使用集成了无线脑电(EEG)的头盔显示器(HMD)，能够 用多焦稳态视觉诱发电位(MfSSVEP)客观评估视野缺损。在……里面 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HMD开发了nGogle原型 显示电极和非一次性电极。我们还对脑电的信号质量进行了基准测试 采集，开发了脑电数据提取和分析方法，并进行了试点研究演示 该设备检测青光眼视野丧失的能力。基于第一阶段令人鼓舞的结果 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 进行NEI STTR第二阶段研究，具体目标是：1)开发定制的头盔显示器 以及增强的无准备电极，以提高nGogger获取用户高信号mfSSVEP的能力- 对视觉刺激的响应的信噪比；2)优化和验证mfSSVEP刺激的设计和 数据分析，以提高使用nGogle评估视觉功能损失的准确性和可重复性；3) 完成关键的临床研究以支持FDA的批准。由于在扩大他们的领域方面缺乏进展 在商业上可用的使用反射光波的头戴式近眼显示器中的视野(FOV) 导轨(ROW)，我们需要开发定制的近眼显示器(NED)，所需的视场为60°对角线 使用微型AMOLED面板和自由曲面(FFS)反射器。本行政副刊适用于 研究将为一个为期六个月的子项目提供必要的资金，以开发定制的近眼 显示和软件图像补偿，以防止扩大视场中的光学失真。这个 然后将使用技术来实现我们第二阶段项目的特定目标，并为nGogle做好准备 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.