Community-based amblyopia screening using a novel device

使用新型设备进行社区弱视筛查

• 批准号: 10641301
• 负责人: Julius Oatts
• 金额: $ 25.81万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641301
• 关键词: Adult; Amblyopia; Biometry; Birefringence; Blinded; Blindness; Boston; California; Child; Childhood; Clinic; Clinical Trials Design; Cluster randomized trial; Collaborations; Communities; Community Outreach; Cost Effectiveness Analysis; Country; Data; Detection; Development; Devices; Diagnosis; Early Diagnosis; Education and Outreach; Educational Intervention; Enrollment; Environment; Epidemiology; Eye; FDA approved; Foundations; Funding; Future; Glaucoma; Goals; Health Care Costs; Human Resources; Income; Infrastructure; International; Intervention; Mentors; Mentorship; Methodology; Monitor; Monocular Vision; Nepal; Ophthalmologist; Ophthalmology; Outcome; Pediatric Hospitals; Performance; Population; Prevalence; Prevention; Randomized; Refractive Errors; Research; Research Design; Research Personnel; Resource-limited setting; Resources; Retina; Risk; Risk Factors; San Francisco; Schools; Services; Specificity; Techniques; Technology; Testing; Training; United States National Institutes of Health; Universities; Urban Community; Vision; Vision Screening; Visual impairment; aged; blind; comparative cost effectiveness; comparative efficacy; cost; cost effective; cost effectiveness; detection sensitivity; diagnostic accuracy; diagnostic screening; diagnostic technologies; economic evaluation; efficacy evaluation; handheld equipment; innovation; invention; low and middle-income countries; low income country; new technology; novel; novel diagnostics; peri-urban; prevent; programs; randomized trial; screening; screening program; standard of care; success

PROJECT SUMMARY Worldwide, more than 500,000 children become blind each year, and the majority of blind children live in low- and middle-income countries (LMICs), where rates of preventable vision loss and blindness are significantly higher. Amblyopia is the leading cause of vision loss in children worldwide. Vision loss from amblyopia can be prevented through early, effective amblyopia screening, though current screening devices have high sensitivity and low specificity which leads to a high number of false positive referrals. This ultimately limits the success of amblyopia screening programs due to increased cost and resource utilization, which is of particular concern in LMICs and low resource settings. This proposal will evaluate the efficacy and cost-effectiveness of two amblyopia screening devices and screening strategies: a current standard device, autorefractor (AR), which only detects amblyopia risk factors, and a novel device, retinal birefringence scanner (RBS), which detects amblyopia directly. Aim 1 of this proposal will compare the performance of the AR and RBS devices for detecting amblyopia in a clinic-based setting in Nepal. Aim 2 will compare the devices in a community-based setting in Nepal. Aim 3 will compare the cost-effectiveness of these two amblyopia screening strategies and devices. The feasibility of these Aims is anchored by collaboration with the Village Integrated Eye Worker II (VIEW II) trial, a cluster-randomized trial led by the candidate’s primary mentor, Dr. Jeremy Keenan. The VIEW II trial randomizes adults in peri-urban communities in Nepal to undergo a vision screening intervention by trained community outreach workers. This proposal incorporates several innovations. First, it uniquely leverages a well-established adult vision screening infrastructure to create and evaluate a screening program for children. Second, it will be the first study to directly compare the performance and cost of two amblyopia screening strategies. The candidate, Dr. Julius Oatts is a pediatric ophthalmologist at the University of California, San Francisco (UCSF), whose long-term goal is to become an independent investigator with expertise in diagnostic accuracy studies for novel technologies to diagnose and monitor preventable vision loss in children nationally and internationally. To successfully complete this research, Dr. Oatts will focus on four relevant domains of training: diagnostic accuracy studies, clinical trial design, cost-effectiveness analysis, and epidemiology and biostatistics. His exceptional mentorship team includes his primary mentor, Dr. Jeremy Keenan, Director of International Programs at the Proctor Foundation and PI of the VIEW II trial, and co- mentors Dr. David Hunter, Chief of Ophthalmology at Boston Children’s Hospital, and Dr. Ying Han, Director of the UCSF Glaucoma service. This team, combined with the environment of the Proctor Foundation and UCSF Department of Ophthalmology, will support his development into an NIH-funded independent investigator.

项目摘要 全世界每年有50多万儿童失明，大多数盲童生活在低收入地区， 和中等收入国家（LMIC），这些国家可预防的视力丧失和失明率显著高于 高弱视是全世界儿童视力丧失的主要原因。弱视导致的视力丧失 通过早期有效的弱视筛查来预防，尽管目前的筛查设备具有高灵敏度， 以及导致大量假阳性转诊的低特异性。这最终限制了 弱视筛查计划由于增加的成本和资源利用，这是特别关注的， 中低收入国家和低资源环境。该提案将评估两种药物的功效和成本效益 弱视筛查设备和筛查策略：目前的标准设备，自动验光仪（AR）， 只检测弱视的危险因素，而一种新的设备，视网膜双折射扫描仪（RBS）， 直接弱视。本提案的目标1将比较AR和RBS设备的性能， 在尼泊尔的一家诊所检测弱视。目标2将在基于社区的 设置在尼泊尔。目的3将比较这两种弱视筛查策略的成本效益， 装置.这些目标的可行性是通过与乡村综合眼科工作者II的合作来确定的 (VIEW II）试验，由候选人的主要导师Jeremy Keenan博士领导的群集随机试验。认为 II试验随机选择尼泊尔城郊社区的成年人进行视力筛查干预， 培训社区外展工作者。这项建议包含了几项创新。首先，它独特 利用完善的成人视力筛查基础设施来创建和评估筛查计划 是为了带孩子第二，这将是第一个直接比较两种弱视治疗效果和成本的研究 筛选策略。候选人朱利叶斯·奥茨（Julius Oatts）博士是密歇根大学的儿科眼科医生 加州，旧金山弗朗西斯科（UCSF），其长期目标是成为一名独立的调查员， 在诊断和监测可预防视力丧失的新技术的诊断准确性研究方面的专业知识 儿童在国内和国际。为了成功完成这项研究，奥茨博士将重点关注四个方面。 相关培训领域：诊断准确性研究、临床试验设计、成本效益分析，以及 流行病学和生物统计学。他杰出的导师团队包括他的主要导师杰里米博士 Keenan，普罗克特基金会国际项目主任和VIEW II试验的PI， 导师：波士顿儿童医院眼科主任大卫亨特博士和 UCSF青光眼服务。这个团队，结合普罗克特基金会和加州大学旧金山分校的环境 眼科学系，将支持他发展成为NIH资助的独立研究者。