Methodological variations in estimating apparent progressive visual field loss in clinical trials of glaucoma treatment.
Methodological variations in estimating apparent progressive visual field loss in clinical trials of glaucoma treatment.
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DOI：
10.1001/archopht.117.9.1137
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发表时间：
1999-09
影响因子：
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通讯作者：
Joanne Katz;Nathan Congdon;David S. Friedman
中科院分区：
文献类型：
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作者：
Joanne Katz;Nathan Congdon;David S. Friedman
目的比较3项青光眼治疗大型随机试验中使用的估计视野进展发生率的方法，方法是将这些方法应用于每年获得的平均随访6年的青光眼患者视野测量的共同数据集。方法采用Humphrey视野分析仪（Humphrey Instruments，圣莱安德罗，Calif）的程序30-2，将晚期青光眼干预研究（AGIS）、协作初始青光眼治疗研究（CIGTS）和早期显性青光眼治疗研究（EMGT）所用的方法应用于56例青光眼患者的67只眼，这些患者参加了一项为期10年的青光眼自然史研究。估计每种方法的明显视野进展的发生率。计算方法之间的一致性程度，并比较至明显进展的时间。结果AGIS法、CIGTS法和EMGT法的进展率分别为11%、22%和23%。临床评估发现23%的患者出现进展，但其中只有一半是通过CIGTS或EMGT方法发现的。CIGTS和EMGT的发病率相当，但只有一半的人确定了一种方法也确定了其他。结论：EMGT和CIGTS方法产生的明显进展率是AGIS方法的两倍。尽管EMGT、CIGTS和临床评估率相当，但它们并未将相同的患者确定为发生了实地进展。
OBJECTIVES To compare methods to estimate the incidence of visual field progression used by 3 large randomized trials of glaucoma treatment by applying these methods to a common data set of annually obtained visual field measurements of patients with glaucoma followed up for an average of 6 years. METHODS The methods used by the Advanced Glaucoma Intervention Study (AGIS), the Collaborative Initial Glaucoma Treatment Study (CIGTS), and the Early Manifest Glaucoma Treatment study (EMGT) were applied to 67 eyes of 56 patients with glaucoma enrolled in a 10-year natural history study of glaucoma using Program 30-2 of the Humphrey Field Analyzer (Humphrey Instruments, San Leandro, Calif). The incidence of apparent visual field progression was estimated for each method. Extent of agreement between the methods was calculated, and time to apparent progression was compared. RESULTS The proportion of patients progressing was 11%, 22%, and 23% with AGIS, CIGTS, and EMGT methods, respectively. Clinical assessment identified 23% of patients who progressed, but only half of these were also identified by CIGTS or EMGT methods. The CIGTS and the EMGT had comparable incidence rates, but only half of those identified by 1 method were also identified by the other. CONCLUSIONS The EMGT and CIGTS methods produced rates of apparent progression that were twice those of the AGIS method. Although EMGT, CIGTS, and clinical assessment rates were comparable, they did not identify the same patients as having had field progression.