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

通过使用准确的自动筛查提高管理式医疗环境中的视力结果质量，同时降低成本

• 批准号: 8980323
• 负责人: David G HUNTER
• 金额: $ 14.51万
• 依托单位: REBISCAN, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2016-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8980323
• 关键词: Adopted; Age; Amblyopia; Anisometropia; Blindness; Caring; Child; Childhood; Clinic; Clinical; Clinical Trials; Data; Depth Perception; Development; Devices; Diagnosis; Disease; Early Diagnosis; Enrollment; Evaluation; Eye; Eye diseases; Family; Funding; Gender; Gold; Grant; Health; Healthcare Systems; Lazy Eyes; Managed Care; Masks; Measures; Medical; Methods; Older Population; Ophthalmic examination and evaluation; Outcome; Participant; Patients; Performance; Phase; Population; Preschool Child; Primary Health Care; Provider; Publishing; Quality of Care; Research; Research Support; Retinal; Sampling; Scanning; Sensitivity and Specificity; Site; Small Business Innovation Research Grant; Strabismus; System; Technology; Testing; Time; United States National Institutes of Health; Vision; Vision Screening; Visit; Visual Acuity; Work; base; commercialization; cost; cost effective; cost effectiveness; cycloplegic; deprivation; design; improved; instrument; medical specialties; neglect; pediatrician; primary care setting; public health relevance; screening; sound; standard of care; tv watching; usability

 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.

 描述（由申请人提供）：弱视（“懒惰眼”）和斜视（眼睛错位）是医学眼科疾病，它们是导致儿童可预防视力丧失的主要原因。如果在七岁之前没有发现和纠正，这些症状是不可逆转的，但有一半的病例会被遗漏，因为这些情况并不总是表现出来，而且儿科医生无法可靠地检测到这些情况。当前的医疗保健系统迫切需要一种准确有效的方法来检测学龄前儿童的弱视和斜视，该应用程序旨在表明 REBIScan 的儿科视觉扫描仪能够检测疾病，包括提供者最难诊断的疾病，并且在初级诊所内由非专业用户作为筛查人员，具有高精度。 该研究将在 Kaiser Permanente 系统运营的繁忙、民族和种族多样化的初级保健场所进行，测试结果和效率与当前的护理标准相比。 该 SBIR 申请中提出的研究将完成 PVS 商业化所需的最后一个重要里程碑。虽然该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，并且尚未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、投资者和付款人在商业采用 PVS 之前所需的效率和准确性数据，从而促进儿童的健康结果。一项两阶段研究旨在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儿童的样本人群，初级保健诊所的非专家可以轻松地对这些儿童进行有限的黄金标准检查（视力测试和非散瞳验光）。然后将对一大群年幼的儿童进行关联研究，他们将接受完整的黄金标准考试。 如果这项研究的结果与已发表的针对丰富人群进行的研究相似，那么美国国立卫生研究院将资助一项有潜力改变世界及其检测弱视和斜视方式的技术。