Improving quality vision outcomes in the managed care setting while reducing cost by use of accurate, automated screening

 描述(由申请人提供)：弱视(“懒眼”)和斜视(眼睛错位)是导致儿童可预防的视力丧失的主要原因。如果在7岁之前没有发现和纠正它们，它们是不可逆转的，然而，所有病例中有一半被遗漏，因为这些情况并不总是表现出来，儿科医生无法可靠地检测到这些情况。目前的医疗保健系统迫切需要一种准确而有效的方法来检测学龄前儿童的弱视和斜视，这一应用旨在展示REBIScan的儿科视力扫描仪能够检测疾病，包括提供者最难诊断的疾病，在以非专业用户为筛查者的初级诊所中具有高水平的准确性。这项研究将在Kaiser Permanente系统运营的繁忙、种族和种族多元化的初级保健地点进行，测试结果和效率与当前的护理标准相比。在这项SBIR应用中提出的研究将完成PVS商业化所需的最后几个重要里程碑。虽然这项技术已经在丰富的人群中进行了测试，但还没有研究测试非专业用户在繁忙的儿科环境中进行测试时的设备性能，也没有在初级保健环境中测试可用性。具体目标将通过使用科学严谨的方法来提供临床医生、投资者和付款人在PVS可以商业采用之前所需的效率和准确性数据，从而促进儿童的健康结果。已经设计了一项分两个阶段的研究，将儿科视力扫描仪与当今的护理标准进行比较。第一阶段包括年龄较大的儿童的样本人群，在这些儿童中，初级保健诊所的非专科医生可以轻松地进行有限的黄金标准检查(视力测试和非睫状肌麻痹自动屈光)。然后，将对将接受完整的黄金标准检查的更大一组较小的儿童进行关联研究。如果这项研究的结果与发表的对丰富人群进行的研究类似，那么美国国立卫生研究院将资助一项有可能改变世界的技术及其检测弱视和斜视的方式。

 DESCRIPTION (provided by applicant): Amblyopia ("lazy eye") and strabismus (misaligned eyes) are medical eye conditions that combine as the leading causes of preventable vision loss in children. They are irreversible if not detected and corrected by the age of seven, however half of all cases are missed because the conditions do not always manifest themselves and pediatricians are unable to reliably detect the conditions. The current health care system badly needs an accurate and effective approach toward detecting amblyopia and strabismus in preschool children, and this application aims to show that REBIScan's Pediatric Vision Scanner is capable of detecting disease, including the most difficult for providers to diagnose, with a hig level of accuracy within a primary clinic with lay users as screeners. The study will be conducted in busy, ethnically and racially diverse primary care sites operated by the Kaiser Permanente system, with outcomes and efficiency of testing compared to the current standard of care. The research proposed in this SBIR application will complete the last significant milestones necessary for commercialization of the PVS. While the technology has been tested in enriched populations, there are no studies that test device performance when lay users perform testing in a busy pediatric setting, and usability has not been tested in the primary care setting. The Specific Aims will advance the health outcomes of children by using a scientifically rigorous approach to provide the efficiency and accuracy data that clinicians, investors, and payors require before the PVS can be adopted commercially. A two-phase study has been designed to compare the Pediatric Vision Scanner to the standard of care today. The first phase includes a sample population of older children in whom a limited Gold Standard Examination (visual acuity testing and non-cycloplegic autorefraction) is easily performed by a non-specialist in the primary care clinic. A linkage study will then be performed on a larger group of younger children who will receive the complete Gold Standard Examination. If the results of this study are similar to published studies performed with enriched populations, then the NIH will have funded a technology that has the potential to change the world and the way it detects amblyopia and strabismus.