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: 9305184
• 负责人: David G HUNTER
• 金额: $ 52.01万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9305184
• 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; ethnic diversity; handheld equipment; improved; instrument; medical specialties; neglect; pediatrician; primary care setting; racial diversity; 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，联合收割机是儿童可预防视力丧失的主要原因。如果在7岁之前没有发现和纠正，它们是不可逆转的，但是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发现这些情况。目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，而本应用旨在表明REBIScan的儿科视力扫描仪能够检测疾病，包括最难诊断的疾病，在初级诊所内具有高水平的准确性，普通用户作为筛查者。 本研究将在由Kaiser Permanente系统运营的忙碌繁忙、种族和人种多样化的初级保健中心进行，与当前标准治疗相比，测试结果和效率。 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。虽然该技术已在丰富人群中进行了测试，但没有研究测试非专业用户在忙碌的儿科环境中进行测试时的器械性能，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高儿童的健康结果，以提供临床医生，投资者和付款人在PVS可以商业化之前所需的效率和准确性数据。设计了一项两阶段研究，将儿科视力扫描仪与当今的标准护理进行比较。第一阶段包括年龄较大的儿童样本人群，在这些儿童中，初级保健诊所的非专家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验光）。然后将对一个更大的年龄较小的儿童群体进行联系研究，这些儿童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对丰富人群进行的研究相似，那么NIH将资助一项有可能改变世界及其检测弱视和斜视方式的技术。