Development of a digital photorefractor to detect amblyogenic risk factors

开发用于检测弱源性危险因素的数字折射仪

• 批准号: 7668875
• 负责人: TANNIN J FUJA
• 金额: $ 11.29万
• 依托单位: VIVAKOR, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7668875
• 关键词: 3 year old; Affect; Age; Amblyopia; Anisometropia; Birth; Characteristics; Child; Childhood; Clinical Research; Cohort Studies; Contracts; Cornea; Country; Data; Data Analyses; Detection; Development; Devices; Diagnosis; Early Diagnosis; Eye; Future; General Practitioners; Gold; Image; Image Analysis; In Vitro; Institutes; Investigation; Iowa; Lazy Eyes; Lead; Left; Light; Marketing; Measures; Methods; Monocular Blindness; Motion; Nursery Schools; Ophthalmology; Performance; Phase; Phase I Clinical Trials; Population; Prevention; Process; Protocols documentation; Public Health; Publishing; Reflex action; Refractive Errors; Reporting; Risk Factors; Schools; Screening procedure; Sensitivity and Specificity; Small Business Innovation Research Grant; Solid; Sorting - Cell Movement; Speed; Strabismus; System; Technology; Testing; Thick; Time; Universities; Vision; Vision Screening; Visual impairment; Width; base; cost; cost effective; design; digital; experience; functional disability; improved; in vitro testing; kindergarten; outcome forecast; pediatrician; performance tests; programs; prototype; public health relevance; research clinical testing; research study; time interval; tool; treatment duration; vision development; vision science

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.

描述（由申请人提供）：如果不及时发现和治疗，一只眼睛的视力下降可能会导致弱视眼的单眼失明。大多数视力筛查是在儿童进入幼儿园后进行的；这是弱视治疗的关键检测期之后。早期发现对于良好的预后至关重要。遗憾的是，只有不到 21% 的学前班儿童接受过任何类型的视力筛查。美国国家基因研究所控股公司 (NGIh) 已经建造并开始测试和优化数字光折射仪，可用于筛查学前儿童和识字前儿童的弱源性风险因素。 NGIh 的技术将简化筛查过程并减少视力筛查的总体时间和成本。 NGIh 数字折射仪 (DPR) 将为所有筛查项目提供具有高特异性和灵敏度的设备。具体来说，第一阶段研究的目的是：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率来优化 DPR 性能。这项研究的结果将为设计优化的 DPR 测试产品以进行 II 期临床评估提供必要的数据。公共健康相关性：国家基因研究所控股公司 (NGIh) 正在开发一种数字光折射仪 (DPR)，以协助筛查未识字和未说话儿童的弱视（弱视）。该系统对角膜光反射、明亮新月形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、非接触式工具，可检测单眼失明的重要原因。该第一阶段研究将使用体外方法提供性能优化测试。优化后的 DPR 技术将为未来的 II 期临床研究做好准备。