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 在全球 和中等收入国家（LMIC），可预防视力丧失和失明率显着 更高。弱视是全球儿童视力丧失的主要原因。弱视的视力丧失可能是 尽管当前的筛选设备具有较高的灵敏度 低特异性，导致大量的假阳性转介。这最终限制了 由于成本和资源利用率增加而导致的弱视筛查计划，这在 LMIC和资源较低的设置。该建议将评估两个提案的有效性和成本效益 弱视筛选设备和筛选策略：当前的标准设备，自动折射器（AR），它 仅检测弱视风险因素和一种新型设备，即视网膜双折射扫描仪（RBS），该扫描仪检测到 直接弱视。该提案的目标1将比较AR和RBS设备的性能 在尼泊尔的基于诊所的环境中检测弱视。 AIM 2将比较基于社区的设备 在尼泊尔设置。 AIM 3将比较这两种弱视筛查策略的成本效益，并比较 设备。这些目标的可行性是由与综合眼工ii的村庄合作奠定了基础 （查看II）试验，这是由候选人的主要导师杰里米·基南（Jeremy Keenan）博士领导的集群随机试验。视图 II试验将尼泊尔城市周期社区的成年人随机，以通过 训练有素的社区外展工作者。该提案结合了几项创新。首先，它是独特的 利用成熟的成人视力筛查基础设施来创建和评估筛选计划 适合儿童。其次，这将是第一个直接比较两个弱视的性能和成本的研究 筛选策略。候选人Julius Oatts博士是大学的儿科眼科医生 加利福尼亚州旧金山（UCSF），其长期目标是成为独立调查员 新技术的诊断准确性研究专业知识，以诊断和监测可预防视力丧失 在国内和国际儿童中。为了成功完成这项研究，Oatts博士将专注于四个 培训的相关领域：诊断准确性研究，临床试验设计，成本效益分析和 流行病学和生物统计学。他的出色精神团队包括他的主要精神，杰里米博士。 Keenan，Proctor基金会国际计划主任和View II试验的PI，共同 波士顿儿童医院眼科主任戴维·亨特（David Hunter）博士的导师和汉汉博士 UCSF青光眼服务。该团队与Proctor Foundation和UCSF的环境相结合 眼科系将支持他的发展成为NIH资助的独立调查员。