Ophthalmology. 1994 Aug;101(8):1445-55.
The Advanced Glaucoma Intervention Study (AGIS) is a multicenter, randomized clinical trial designed (1) to determine the better of two surgical management strategies for glaucoma when medical treatment alone no longer adequately controls the disease and (2) to clarify the clinical course and prognosis of open-angle glaucoma after surgical interventions have begun. The investigators of this study have developed quantitative methods to assess the test reliability and measure the severity of glaucomatous visual field defects with the 24-2 threshold program of the Humphrey Visual Field Analyzer. This report details these methods and presents information about long-term fluctuation during a time interval short enough to render change due to disease unlikely.
In AGIS, reliability assessment of automated visual field tests is based on the number of questions asked; percent of fixation losses, false-positive responses, and false-negative responses; and amount of short-term fluctuation. The AGIS visual field defect score is based on the number and depth of clusters of adjacent depressed test sites in the upper and lower hemifields and in the nasal area of the total deviation printout of the threshold program single-field test STATPAC-2 analysis. The score ranges from 0 (no defect) to 20 (all test sites deeply depressed). The fluctuation in score between two tests obtained during an interval preceding AGIS surgical interventions, ranging from 1 day to 6 weeks on 756 eyes of 562 patients, is analyzed.
The scores of the first visual field tests, which determined eligibility for the study, range from 1 to 17. Large positive or negative interest fluctuations (absolute changes of 4 or more) occurred in the second tests for 16% of eyes; more scores improved (11%) than worsened (5%). The frequency of large fluctuations tended to increase as the time interval between tests increased. Absolute interest fluctuations were independent of age.
For visual field tests obtained with the automated perimeter, AGIS investigators have developed objective, quantitative methods of scoring test reliability and severity of glaucomatous field loss. For 16% of eyes, long-term fluctuations were large enough (> or = 4 points) to suggest improvement or worsening of the glaucomatous defect even though the interval in which the fluctuations occurred was short enough (median time, approximately 1 week) to render changes in disease status unlikely.
高级青光眼干预研究(AGIS)是一项多中心随机临床试验,旨在:(1)确定在单纯药物治疗无法充分控制病情时,两种青光眼手术治疗策略中哪种更佳;(2)明确手术干预开始后开角型青光眼的临床病程和预后。本研究的研究者已开发出定量方法,以评估使用Humphrey视野分析仪的24-2阈值程序进行视野检测的可靠性,并测量青光眼性视野缺损的严重程度。本报告详细介绍了这些方法,并提供了在短时间间隔内长期波动的信息,这段时间间隔短到因疾病导致变化的可能性不大。
在AGIS中,自动视野检测的可靠性评估基于所提问题的数量、固视丢失率、假阳性反应率和假阴性反应率以及短期波动量。AGIS视野缺损评分基于阈值程序单视野检测STATPAC-2分析的总偏差打印图中上下半视野及鼻侧区域相邻低检测点簇的数量和深度。评分范围为0(无缺损)至20(所有检测点深度降低)。分析了562例患者756只眼在AGIS手术干预前1天至6周的间隔期内两次检测之间的评分波动情况。
确定研究入选资格时进行的首次视野检测评分范围为1至17。16%的眼在第二次检测中出现了较大的正向或负向评分波动(绝对变化≥4);评分改善的眼(11%)多于恶化的眼(5%)。随着两次检测之间时间间隔的增加,大波动的频率趋于增加。绝对评分波动与年龄无关。
对于使用自动视野计获得的视野检测,AGIS研究者已开发出客观、定量的方法来评估检测可靠性和青光眼视野缺损的严重程度。对于16%的眼,尽管波动发生的间隔期短到(中位时间约1周)疾病状态变化的可能性不大,但长期波动仍大到足以(≥4分)提示青光眼缺损有所改善或恶化。