Measurement and analysis of visual acuity in multicenter randomized clinical trials in the United States: Findings from a survey
Measurement and analysis of visual acuity in multicenter randomized clinical trials in the United States: Findings from a survey
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DOI：
10.1076/opep.10.3.149.15080
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发表时间：
2003-07-01
影响因子：
1.8
通讯作者：
Hawkins, BS
中科院分区：
文献类型：
--
作者：
Dong, LM;Marsh, MJ;Hawkins, BS
目的介绍美国国家眼科研究所（National Eye Institute，NEI）在美国眼科多中心随机临床试验中使用的视力（visual acuity，VA）测试和评分方法。要纳入调查，研究必须在一篇或多篇出版物中报告VA或基于VA的患者资格，大多数研究受试者年龄≥ 13岁，患者人群主要或仅来自美国。根据研究程序手册和出版物中提供的信息，完成每项研究的标准调查表。调查结果进行了总结，并显示频率distributions.RESULTS调查包括24项研究，每个招募在1972年至1999年期间开始。VA是19项（79%）研究的研究合格性标准之一，VA或VA变化是12项（50%）研究的主要结局。在1982年发表ETDRS图表后开始的19项研究中，有16项采用了ETDRS图表。除文件中规定的一项研究外，所有研究均回顾了在多个VA测试距离处进行VA测试。对于使用ETDRS图表的研究，将在不同测试距离获得的VA评分转换为通用量表的方法分为两类：II研究使用的方法在性质上类似于黄斑光凝研究中首次报道的方法，7项研究使用了与氪星首次报道的方法相似的方法，新血管形成研究的氩回归。结论ETDRS图表和自定义灯箱的发展导致VA测试图表和图表照明更加均匀。然而，VA测量方案的细节因研究而异。为了确保研究和眼部状况之间的数据具有可比性，有一个标准的VA测试和评分方案是有用的，该方案规定测试不同水平的视力，推荐一种将不同测试距离的分数转换为通用量表的单一方法，以及用于计算VA平均值和变化的“超出图表”VA水平的标准转换。
PURPOSE To describe visual acuity (VA) testing and scoring methods used in multicenter randomized clinical trials in ophthalmology in the United States (USA) sponsored by the National Eye Institute (NEI).METHODS A survey was conducted among multicenter studies in the US that included one or more randomized clinical trials and were sponsored by the NEI, National Institutes of Health. To be included in the survey, a study had to have VA reported in one or more publications or patient eligibility based on VA, a majority of study subjects 13 years of age or older, and a patient population primarily or exclusively from the US. A standard survey form was completed for each study based on information presented in the study manual of procedures and publications. Findings were summarized and displayed with frequency distributions.RESULTS The survey included 24 studies, each with enrollment initiated in the period 1972 to 1999. VA was one of the study eligibility criteria for 19 (79%) studies, and VA or change in VA was the primary outcome in 12 (50%) studies. ETDRS charts have been employed in 16 of 19 studies initiated after the charts were published in 1982. All studies but one specified in the documents reviewed that VA testing was performed at multiple VA test distances. For studies that used ETDRS charts, methods of converting VA scores obtained at different test distances to a common scale fell into two categories: II studies used a method similar in nature to that first reported in the Macular Photocoagulation Study, and 7 studies used a method similar in nature to that first reported in the Krypton-Argon Regression of Neovascularization Study.CONCLUSION The development of the ETDRS charts and a custom light box has led to more uniformity in VA test charts and chart illumination. However, details of VA measurement protocols vary widely from study to study. To assure comparable data across studies and ocular conditions, it would be useful to have a standard VA testing and scoring protocol with provisions for testing different levels of visual acuity that recommends a single method for converting scores from different test distances to a common scale and standard conversion of "off the chart" VA levels for calculation of means and changes in VA.