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.

项目概要 全球每年有超过 500,000 名儿童失明，大多数失明儿童生活在低收入国家 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着升高 弱视是全球儿童视力丧失的主要原因。 尽管当前的筛查设备具有高灵敏度，但可以通过早期有效的弱视筛查来预防 特异性低，导致大量误报转介，这最终限制了成功。 由于成本和资源利用率增加，弱视筛查项目尤其令人担忧 该提案将评估两个中低收入国家的功效和成本效益。 弱视筛查设备和筛查策略：当前的标准设备自动验光仪（AR）， 仅检测弱视危险因素，而一种新颖的设备，视网膜双折射扫描仪（RBS），可以检测 该提案的目标 1 将比较 AR 和 RBS 设备的性能。 在尼泊尔的诊所环境中检测弱视目标 2 将比较社区中的设备。 目标 3 将比较这两种弱视筛查策略的成本效益 这些目标的可行性是通过与 Village Integrated Eye Worker II 的合作来实现的。 (VIEW II) 试验，这是一项由候选人的主要导师 Jeremy Keenan 博士领导的整群随机试验。 II 试验随机抽取尼泊尔城郊社区的成年人进行视力筛查干预 训练有素的社区外展工作人员。该提案包含多项创新。 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 其次，这将是第一个直接比较两种弱视的性能和成本的研究。 候选人朱利叶斯·奥茨 (Julius Oatts) 博士是纽约大学的儿科眼科医生。 加利福尼亚州旧金山（UCSF），其长期目标是成为一名独立调查员 诊断和监测可预防视力丧失新技术的诊断准确性研究方面的专业知识 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 他的杰出导师团队包括他的主要导师杰里米博士。 Keenan，Proctor 基金会国际项目总监兼 VIEW II 试验的 PI，以及共同 导师：波士顿儿童医院眼科主任 David Hunter 博士和眼科主任 Han Ying 博士 UCSF 青光眼服务团队，结合 Proctor 基金会和 UCSF 的环境。 眼科将支持他发展成为 NIH 资助的独立研究者。