Diversity Supplement: Village Integrated Eye Worker Trial II Validation Study

多样性补充：村庄综合眼科工作者试验 II 验证研究

• 批准号: 10361062
• 负责人: Jeremy David Keenan
• 金额: $ 9.33万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10361062
• 关键词: Age; Age related macular degeneration; Ancillary Study; Blindness; Clinic; Clinical Trials; Clinics and Hospitals; Cluster randomized trial; Communities; Cost Analysis; Detection; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Diagnostic tests; Disease; Disease Progression; Early Diagnosis; Enrollment; Eye; Eye diseases; Funding; Fundus; Fundus photography; General Population; Glaucoma; Goals; Grant; Hospitals; Image; Inferior; Intervention; Intraocular pressure test; Learning; Low Prevalence; Masks; Medical Students; Medicine; Mentors; Methods; Modality; Nepal; Ophthalmic examination and evaluation; Ophthalmologist; Ophthalmology; Optical Coherence Tomography; Parents; Participant; Patients; Phase; Photography; Population; Prevalence; Progressive Disease; Randomized; Reference Standards; Retina; Retinal Diseases; Running; Screening procedure; Sensitivity and Specificity; Series; Swelling; Technology; Telemedicine; Test Result; Testing; Tissues; Validation; Vision; Visit; Visual Fields; Visual impairment; Work; automated algorithm; base; career; cost effective; design; diagnostic accuracy; effective therapy; effectiveness evaluation; experience; field study; new technology; population based; prevent; programs; randomized trial; retinal imaging; screening; screening program; validation studies

PROJECT SUMMARY Diabetic retinopathy is a significant cause of vision impairment worldwide. Patients with diabetes should be screened for diabetic retinopathy since the retinal findings can be detected before the patient is symptomatic and because there are effective treatments to prevent progression of disease. Patients are most often screened with an indirect ophthalmologic examination by an ophthalmologist, or by a retinal photograph. In telemedicine programs, a non-ophthalmologist technician can perform the photography, and then a grading center can grade the images. Optical coherence tomography (OCT) is a newer technology for imaging the retina. OCT provides cross-sectional views through the retinal tissue, and thus provides better information on retinal swelling, which can be more difficult to assess on photography. Moreover, OCT is better than photography for assessing features of other screenable eye diseases, such as glaucoma and age-related macular degeneration. Thus, OCT could offer a simpler screening test for multiple eye diseases at once. However, OCT has not been fully validated for use specifically as a screening test for diabetic retinopathy. In this supplemental study, we add an ancillary study to an existing randomized trial called the Village- Integrated Eye Workers II (VIEW II) trial. In VIEW II, communities in Nepal are randomized either to enhanced eye disease screening with OCT, or no enhanced screening. Participants with abnormal OCT findings are referred to the local eye hospital for a comprehensive eye examination. In this supplemental study, the use of OCT as a screening test will be validated against fundus photography. A series of participants with diabetes will undergo both OCT and fundus photography, and the images will be graded for diabetic retinopathy. The diagnostic accuracy of each test (i.e., OCT and photography) will be judged relative to an ophthalmologist examination. The hypothesis of the study is that the accuracy of OCT for diagnosing diabetic retinopathy will not be inferior to that of photography. The supplemental study will be performed in two populations: first, patients being seen in the retina clinic, and second, patients referred in from the VIEW II screening visit. This supplemental study will provide additional validation of the OCT intervention for the existing clinical trial, and will also be useful for telemedicine programs throughout the world.

项目摘要 糖尿病性视网膜病是全球视力障碍的重要原因。糖尿病患者应 筛查糖尿病性视网膜病，因为可以在患者进行之前检测到视网膜检查结果 有症状，并且因为有有效的治疗方法可以预防疾病的进展。患者最多 经常通过眼科医生或视网膜照片进行间接的眼科检查。 在远程医疗计划中，非跨科学家技术人员可以执行摄影，然后进行评分 中心可以对图像进行评分。 光学相干断层扫描（OCT）是一种用于对视网膜进行成像的新技术。 OCT提供 通过视网膜组织的横截面视图，因此提供了有关视网膜肿胀的更好信息， 在摄影上可能更难评估。而且，十月胜于评估的摄影 其他可筛查眼病的特征，例如青光眼和与年龄相关的黄斑变性。因此， OCT可以一次为多种眼科疾病提供更简单的筛查测试。但是，十月还没有完全 经过验证，专门用作糖尿病性视网膜病的筛查测试。 在这项补充研究中，我们在现有的称为村庄的随机试验中添加了一项辅助研究 - 综合眼工II（查看II）试验。根据II，尼泊尔的社区要么随机分配以增强 通过OCT进行眼病筛查，或没有增强的筛查。异常发现的参与者是 转交给当地的眼科医院进行全面的眼睛检查。在这项补充研究中，使用 OCT作为筛查测试将被验证针对Feldus摄影。一系列糖尿病参与者 将同时进行OCT摄影和眼底摄影，并且这些图像将用于糖尿病性视网膜病。这 每个测试的诊断准确性（即OCT和摄影）将根据眼科医生进行判断 考试。该研究的假设是诊断糖尿病性视网膜病的OCT的准确性将 不如摄影。补充研究将在两个人群中进行：首先， 在视网膜诊所看到的患者，其次是从视图II筛查就参考的患者。 这项补充研究将为现有临床的OCT干预提供其他验证 试验，对于全球远程医疗计划也将很有用。