Objective To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma. Design Pragmatic multicentre randomised controlled trial. Setting 27 secondary care glaucoma departments in the UK. Participants 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. Interventions Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) Main outcome measures Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. Secondary outcomes: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety. Results At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval −1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference −2.8 (−3.8 to −1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare. Conclusion Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. Trial registration Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: [ISRCTN56878850][1]. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN56878850

中文翻译：

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晚期青光眼的初级小梁切除术：实用的多中心随机对照试验 (TAGS)

目的 确定初级小梁切除术或初级药物治疗是否在晚期青光眼患者的生活质量、临床有效性和安全性方面产生更好的结果。设计实用的多中心随机对照试验。在英国设置 27 个二级护理青光眼科室。参与者 453 名成年人在 2014 年 6 月 3 日至 2017 年 5 月 31 日期间至少一只眼（Hodapp 分类）出现新诊断的晚期开角型青光眼。 =226) 主要结果测量 主要结果：在 24 个月时使用视觉功能问卷 25 (VFQ-25) 测量的视觉特定生活质量。次要结果：一般健康状况、青光眼相关的生活质量、临床有效性（眼压、视野、视力）和安全性。结果 在 24 个月时，小梁切除术和医疗组的平均 VFQ-25 评分分别为 85.4 (SD 13.8) 和 84.5 (16.3)（平均差异 1.06，95% 置信区间 -1.32 至 3.43；P=0.38）。小梁切除术的平均眼压为 12.4 (SD 4.7) mm Hg，药物治疗的平均眼压为 15.1 (4.8) mm Hg（平均差为 -2.8（-3.8 至 -1.7） mm Hg；P<0.001）。小梁切除术组 88 名 (39%) 患者和药物治疗组 100 名 (44%) 患者发生不良事件（相对风险 0.88，95% 置信区间 0.66 至 1.17；P=0.37）。严重的副作用很少见。结论与主要药物相比，原发性小梁切除术具有相似的生活质量和安全性结果，并且眼压较低。试验注册卫生技术评估 (NIHR-HTA) 计划（项目编号：12/35/38）。ISRCTN 注册：[ISRCTN56878850][1]。[1]：/external-ref?link_type=ISRCTN&access_num=ISRCTN56878850