DIABETIC MACULAR EDEMA--CLASSIFICATION & NATURAL COURSE

描述(调查者摘要)“大量信息是 关于糖尿病视网膜病变的自然病程的可用信息 从早期的非增殖性到晚期增殖性的进展 阶段，视网膜病变严重程度的一个有用的全面量表 发展起来的。黄斑水肿，糖尿病视网膜病变的共同特征 视力丧失的一个常见原因，不是视网膜病变严重程度的一部分 规模，其临床特征和自然病程一直不太好。 有记录在案。来自NEI赞助的早期治疗的现有数据 糖尿病视网膜病变研究(ETDRS)和糖尿病视网膜病变研究(DRS)， 其中大量患者伴有不同程度的黄斑水肿 并对不同的视网膜病变严重程度进行了数年的跟踪调查 (最初随机分配一只眼睛推迟拍照- 凝聚)，提供了记录自然的独特机会 并对糖尿病黄斑水肿的病程进行分类。 具体地说，这个项目的目标是：(1)开发一个分类 基于眼底照相和荧光素的黄斑水肿 血管造影特征；(2)开发一种量表，以表征 其总体严重性；(3)记录其自然过程；(4) 确定变化的风险因素(人口、系统和眼睛) 在视力和形态特征上。除了 使用交叉表和表格仔细检查关系 Spearman相关系数、多变量分析(包括 Logistic回归)将被用于建立预测价值 感兴趣的结果的选定基线变量。自.以来 观察值随着时间的推移是相关的，混合效应模型描述了 由Laird和Ware用高效的计算方法实现 林德斯特罗姆和贝茨，将被利用。这些分析的结果 将被转化为面向临床的分类 严重程度量表对研究人员评估治疗方法和 眼科医生管理病人。

DESCRIPTION (Investigator's Abstract) "Considerable information is available concerning the natural course of diabetic retinopathy as it progresses from the early nonproliferative to the advanced proliferative stage, and a useful overall scale of retinopathy severity has been developed. Macular edema, a common feature of diabetic retinopathy and a common cause of visual loss, is not a part of the retinopathy severity scale, and its clinical features and natural course have not been well documented. Existing data from the NEI-sponsored Early Treatment Diabetic Retinopathy Study (ETDRS) and Diabetic Retinopathy Study (DRS), in which large numbers of patients with varying degrees of macular edema and varying retinopathy severity were followed for several years (initially with one eye randomly assigned to deferral of photo- coagulation), provide a unique opportunity to document the natural course of diabetic macular edema and to develop a classification. Specifically, goals of this project are: (1) to develop a classification of macular edema based upon fundus photographic and fluorescein angiographic characteristics; (2) to develop a scale that characterizes its overall severity; (3) to document its natural course; and (4) to determine risk factors (demographic, systemic, and ocular) for change in visual acuity and morphologic characteristics. In addition to careful examination of relationships using cross-tabulations and Spearman correlation coefficients, multivariate analyses (including logistic regression) will be used to establish the predictive value of selected baseline variables for the outcomes of interest. Since observations are correlated over time, the mixed effects model described by Laird and Ware, implemented with the efficient computational methods of Lindstrom and Bates, will be utilized. Results of these analyses will be translated into a clinically oriented classification and severity scale useful both to researchers evaluating treatments and to ophthalmologists managing patients."