Miglior Stefano, Zeyen Thierry, Pfeiffer Norbert, Cunha-Vaz Jose, Torri Valter, Adamsons Ingrid
Ophthalmology. 2005 Mar;112(3):366-75. doi: 10.1016/j.ophtha.2004.11.030.
The European Glaucoma Prevention Study (EGPS) seeks to evaluate the efficacy of reduction of intraocular pressure (IOP) by dorzolamide in preventing or delaying primary open-angle glaucoma (POAG) in patients affected by ocular hypertension (OHT).
Randomized, double-masked, controlled clinical trial.
One thousand eighty-one patients (age, > or =30 years) were enrolled by 18 European centers. The patients fulfilled a series of inclusion criteria, including: IOP 22 to 29 mmHg; 2 normal and reliable visual fields (on the basis of mean deviation and corrected pattern standard deviation or corrected loss variance of standard 30/II Humphrey or Octopus perimetry); normal optic disc as determined by the Optic Disc Reading Center.
Patients were randomized to treatment with dorzolamide or placebo (the vehicle of dorzolamide).
Efficacy end points were visual field, optic disc changes, or both. A visual field change during follow-up had to be confirmed by 2 further positive tests. Optic disc change was defined on the basis of the agreement of 2 of 3 independent observers evaluating optic disc stereo slides. The safety end point was an IOP of more than 35 mmHg on 2 consecutive examinations.
During the course of the study, the mean percent reduction in IOP in the dorzolamide group was 15% after 6 months and 22% after 5 years. Mean IOP declined by 9% after 6 months and by 19% after 5 years in the placebo group. At 60 months, the cumulative probability of converting to an efficacy end point was 13.4% in the dorzolamide group and 14.1% in the placebo group (hazard ratio, 0.86; 95% confidence interval [CI], 0.58-1.26; P = 0.45). The cumulative probability of developing an efficacy or a safety end point was 13.7% in the dorzolamide group and 16.4% in the placebo group (hazard ratio, 0.73; 95% CI, 0.51-1.06; P = 0.1).
Dorzolamide reduced IOP by 15% to 22% throughout the 5 years of the trial. However, the EGPS failed to detect a statistically significant difference between medical therapy and placebo in reducing the incidence of POAG among a large population of OHT patients at moderate risk for developing POAG, because placebo also significantly and consistently lowered IOP.
欧洲青光眼预防研究（EGPS）旨在评估多佐胺降低眼压（IOP）在预防或延缓高眼压症（OHT）患者原发性开角型青光眼（POAG）方面的疗效。
随机、双盲、对照临床试验。
18个欧洲中心招募了1081名患者（年龄≥30岁）。这些患者符合一系列纳入标准，包括：眼压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或标准30/II Humphrey或Octopus视野计的校正损失方差）；视盘阅读中心确定视盘正常。
患者被随机分配接受多佐胺或安慰剂（多佐胺的赋形剂）治疗。
疗效终点为视野、视盘变化或两者皆有。随访期间的视野变化必须经另外2次阳性检查确认。视盘变化根据3名独立观察者中的2名对视盘立体幻灯片评估的一致性来定义。安全终点是连续2次检查眼压超过35 mmHg。
在研究过程中，多佐胺组眼压在6个月后平均降低15%，5年后降低22%。安慰剂组眼压在6个月后平均下降9%，5年后下降19%。在60个月时，多佐胺组转换为疗效终点的累积概率为13.4%，安慰剂组为14.1%（风险比，0.86；95%置信区间[CI]，0.58 - 1.26；P = 0.45）。多佐胺组出现疗效或安全终点的累积概率为13.7%，安慰剂组为16.4%（风险比，0.73；95% CI，0.51 - 1.06；P = 0.1）。
在整个5年的试验中，多佐胺使眼压降低了15%至22%。然而，欧洲青光眼预防研究未能在大量有中度POAG发病风险的OHT患者中检测到药物治疗与安慰剂在降低POAG发病率方面的统计学显著差异，因为安慰剂也显著且持续地降低了眼压。
