Miglior Stefano, Pfeiffer Norbert, Torri Valter, Zeyen Thierry, Cunha-Vaz Jose, Adamsons Ingrid
Università di Milano Bicocca, Policlinico di Monza, Via Amati 111, 20052, Monza, Mi, Italy.
Ophthalmology. 2007 Jan;114(1):3-9. doi: 10.1016/j.ophtha.2006.05.075. Epub 2006 Oct 27.
To evaluate the predictive factors of open-angle glaucoma (OAG) in patients affected by ocular hypertension enrolled in the European Glaucoma Prevention Study (EGPS).
Randomized, double-masked, controlled clinical trial.
One thousand seventy-seven patients, > or =30 years old, were enrolled at 18 European centers. The patients met inclusion criteria: intraocular pressure, 22 to 29 mmHg; 2 normal and reliable visual fields (VFs) (on the basis of mean deviation and corrected pattern standard deviation [PSD]); and a normal optic disc, as determined by an optic disc reading center.
Treatment with dorzolamide or a placebo (the vehicle of dorzolamide) in one or both eyes.
Efficacy end points were VF and/or optic disc changes. Baseline demographic and clinical data were collected before randomization, except for corneal thickness measurements, which were determined during follow-up. Proportional hazards models were used to identify factors that predicted which participants in the EGPS had developed OAG.
In multivariate analyses, factors that predicted the development of OAG included older age (hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.04-1.69), larger vertical cup-to-disc (C/D) ratio (HR, 1.34; 95% CI, 1.14-1.58), larger vertical C/D ratio asymmetry (HR, 1.46; 95% CI, 1.11-1.93), higher PSD (HR, 1.66; 95% CI, 1.15-2.38), and lesser central corneal thickness (HR, 1.32; 95% CI, 1.05-1.67).
Baseline age, vertical C/D ratio, vertical C/D ratio asymmetry, and PSD were good predictors of the onset of OAG in the EGPS. Central corneal thickness was found to be a powerful predictor of the development of OAG. The EGPS results agree with the findings of the Ocular Hypertension Treatment Study and support the need for a thorough evaluation of patients with ocular hypertension.
评估纳入欧洲青光眼预防研究(EGPS)的高眼压症患者开角型青光眼(OAG)的预测因素。
随机、双盲、对照临床试验。
18个欧洲中心招募了1077名年龄≥30岁的患者。患者符合纳入标准:眼压为22至29 mmHg;2个正常且可靠的视野(基于平均偏差和校正模式标准差[PSD]);以及由视盘阅读中心确定的正常视盘。
单眼或双眼使用多佐胺或安慰剂(多佐胺的赋形剂)治疗。
疗效终点为视野和/或视盘变化。除角膜厚度测量在随访期间确定外,基线人口统计学和临床数据在随机分组前收集。使用比例风险模型确定预测EGPS中哪些参与者发生OAG的因素。
在多变量分析中,预测OAG发生的因素包括年龄较大(风险比[HR],1.32;95%置信区间[CI],1.04 - 1.69)、垂直杯盘比(C/D)较大(HR,1.34;95%CI,1.14 - 1.58)、垂直C/D比不对称性较大(HR,1.46;95%CI,1.11 - 1.93)、较高的PSD(HR,1.66;95%CI,1.15 - 2.38)以及中央角膜厚度较小(HR,1.32;95%CI,1.05 -