Diversity Supplement: Village Integrated Eye Worker Trial II Validation Study

项目总结 糖尿病视网膜病变是世界范围内视力受损的一个重要原因。糖尿病患者应该 对糖尿病视网膜病变进行筛查，因为视网膜发现可以在患者就诊前检测到 有症状，因为有有效的治疗方法来防止疾病的发展。病人最多的是 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，非眼科技术人员可以进行拍照，然后进行评分 中心可以对图像进行分级。 光学相干断层成像(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切面观察，从而提供更好的关于视网膜肿胀的信息，这 在摄影上可能更难评估。此外，OCT在评估方面比摄影更好 其他可筛查眼病的特征，如青光眼和老年性黄斑变性。因此， OCT可以为多种眼病提供一种更简单的筛查测试。然而，OCT还没有完全 专门用于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的基础上增加了一项辅助研究，名为The Village- 综合眼科工作者II(VIEW II)试验。在VIEW II中，尼泊尔的社区被随机分配到增强 使用OCT进行眼病筛查，或不进行增强筛查。OCT发现异常的参与者为 转介到当地眼科医院做了全面的眼科检查。在这项补充研究中，使用 OCT作为筛查测试将与眼底照相进行验证。一系列患有糖尿病的参与者 将接受OCT和眼底摄影，图像将被分级为糖尿病视网膜病变。这个 每项检查(即OCT和摄影)的诊断准确性将与眼科医生进行比较 考试。这项研究的假设是OCT对诊断糖尿病视网膜病变的准确性将 不逊色于摄影。补充研究将在两个人群中进行：第一， 首先是在视网膜诊所就诊的患者，其次是从VIEW II筛查访问转诊的患者。 这项补充研究将为现有临床的OCT干预提供额外的验证 试用，也将对世界各地的远程医疗项目有用。

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.