Diversity Supplement: Village Integrated Eye Worker Trial II Validation Study

项目摘要 糖尿病视网膜病变是世界范围内视力损害的重要原因。糖尿病患者应 糖尿病视网膜病变的筛查，因为视网膜的发现可以在患者被检查之前检测到。 症状，因为有有效的治疗方法来防止疾病的进展。患者最 通常通过眼科医生的间接眼科检查或通过视网膜照片进行筛查。 在远程医疗项目中，非眼科医生的技术人员可以进行摄影，然后进行分级 中心可以对图像进行分级。 光学相干断层扫描（OCT）是一种较新的视网膜成像技术。OCT提供 通过视网膜组织的横截面视图，从而提供了更好的信息视网膜肿胀， 在摄影上更难评估。而且，OCT比照相更好地用于评估 其他可筛查的眼部疾病的特征，如青光眼和年龄相关性黄斑变性。因此，在本发明中， OCT可以同时为多种眼病提供更简单的筛查测试。然而，华侨城还没有完全 经验证可专门用作糖尿病视网膜病变的筛查试验。 在这项补充研究中，我们在现有的随机试验中增加了一项辅助研究，称为Village- Integrated Eye Workers II（VIEW II）试验。在VIEW II中，尼泊尔的社区被随机分配到 用OCT进行眼病筛查，或不进行增强筛查。OCT结果异常的受试者为 转介到当地眼科医院作全面眼科检查。在这项补充研究中，使用 OCT作为筛选检查将根据眼底照相进行验证。一系列糖尿病患者 将接受OCT和眼底照相，并对图像进行糖尿病视网膜病变分级。的 每个测试的诊断准确性（即，OCT和摄影）将相对于眼科医生进行判断 考试本研究的假设是OCT诊断糖尿病视网膜病变的准确性 不亚于摄影。补充研究将在两个人群中进行：第一， 在视网膜诊所就诊的患者，以及第二，从VIEW II筛选访视转介的患者。 本补充研究将为现有临床试验提供OCT干预的额外确认。 试验，也将是有益的远程医疗计划在世界各地。

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.