Development of a digital photorefractor to detect amblyogenic risk factors

描述（由申请人提供）：如果不及时发现和治疗，单眼视力下降会导致弱视眼单眼失明。大多数视力检查是在孩子开始上幼儿园后进行的；这是弱视治疗的关键检测期之后。早期发现对良好预后至关重要。不幸的是，只有不到21%的学龄前儿童接受过任何形式的视力筛查。美国国家遗传研究所控股有限公司（NGIh）已经建立并开始测试和优化一种数字光折射器，该折射器可用于筛查语言和识字前儿童的弱智风险因素。NGIh的技术将简化筛查过程，减少视力筛查的总体时间和成本。NGIh数字光折射仪（DPR）将为所有筛查项目提供高特异性和高灵敏度的设备。具体而言，第一阶段的研究旨在：1)优化闪光宽度参数，2)优化曝光时间和图像间隔参数，3)通过测试额外的闪光偏心来优化DPR性能。本研究结果将为优化后的DPR试验产品的设计及临床二期评价提供必要的数据。公共卫生相关性：国家遗传研究所控股有限公司（NGIh）正在开发一种数字光折射器（DPR），以帮助筛查未识字和不会说话的儿童是否弱视（弱视）。该系统对角膜光反射、明亮新月和布鲁克纳反射进行成像，以筛查儿童的弱视危险因素。它代表了一种更快、非侵入性、非接触性的工具，可以检测单眼失明的主要原因。这个第一阶段的研究将使用体外方法为性能优化提供测试。优化后的DPR技术将为未来的II期临床研究做好准备。

DESCRIPTION (provided by applicant): If left undetected and untreated, reduced vision in one eye can lead to monocular blindness in an amblyopic eye. Most vision screening is conducted on children once they have started kindergarten; this is after the critical detection period for the treatment of amblyopia. Early detection is essential for favorable prognosis. Unfortunately less than 21% of pre-kindergarten children receive any sort of vision screening. National Genecular Institute Holdings, Inc. (NGIh) has built and begun testing and optimization of a digital photorefractor that can be used to screen preverbal and preliterate children for amblyogenic risk factors. NGIh's technology will streamline the screening process and reduce the overall time and cost of vision screening. The NGIh Digital Photorefractor (DPR) will offer all screening programs a device with a high specificity and sensitivity. Specifically this Phase I study aims to: 1) Optimize the parameter of flash width, 2) Optimize the parameter of exposure time and image interval, and 3) Optimize DPR performance by testing additional flash eccentricities. Results from this study will provide the necessary data for the design of the optimized DPR test product for clinical evaluation in Phase II. PUBLIC HEALTH RELEVANCE: National Genecular Institute Holdings, Inc. (NGIh) is developing a digital photorefractor (DPR) to assist in the screening of preliterate and preverbal children for amblyopia (lazy eye). This system images the corneal light reflex, bright crescents, and the Bruckner reflex to screen children for amblyogenic risk factors. It represents a faster, non-invasive, non-contact tool to detect significant causes of monocular blindness. This Phase I study will provide testing for performance optimization using in-vitro methods. The optimized DPR technology will then be ready for future Phase II clinical studies.