The Centre for Healthcare Randomised Trials (CHaRT), Health Sciences Building, Foresterhill, University of Aberdeen, Aberdeen, AB25 2ZD, UK.
Trials. 2011 May 23;12:133. doi: 10.1186/1745-6215-12-133.
Glaucoma is the leading cause of irreversible blindness. Although primary open-angle glaucoma is more common, primary angle-closure glaucoma (PACG) is more likely to result in irreversible blindness. By 2020, 5·3 million people worldwide will be blind because of PACG. The current standard care for PACG is a stepped approach of a combination of laser iridotomy surgery (to open the drainage angle) and medical treatment (to reduce intraocular pressure). If these treatments fail, glaucoma surgery (eg, trabeculectomy) is indicated. It has been proposed that, because the lens of the eye plays a major role in the mechanisms leading to PACG, early clear lens extraction will improve glaucoma control by opening the drainage angle. This procedure might reduce the need for drugs and glaucoma surgery, maintain good visual acuity, and improve quality of life compared with standard care.EAGLE aims to evaluate whether early lens extraction improves patient-reported, clinical outcomes, and cost-effectiveness, compared with standard care.
METHODS/DESIGN: EAGLE is a multicentre pragmatic randomized trial. All people presenting to the recruitment centres in the UK and east Asia with newly diagnosed PACG and who are at least 50 years old are eligible.The primary outcomes are EQ-5D, intraocular pressure, and incremental cost per quality adjusted life year (QALY) gained. Other outcomes are: vision and glaucoma-specific patient-reported outcomes, visual acuity, visual field, angle closure, number of medications, additional surgery (e.g., trabeculectomy), costs to the health services and patients, and adverse events.A single main analysis will be done at the end of the trial, after three years of follow-up. The analysis will be based on all participants as randomized (intention to treat). 400 participants (200 in each group) will be recruited, to have 90% power at 5% significance level to detect a difference in EQ-5D score between the two groups of 0·05, and a mean difference in intraocular pressure of 1·75 mm Hg. The study will have 80% power to detect a difference of 15% in the glaucoma surgery rate.
ISRCTN44464607.
青光眼是导致不可逆性失明的主要原因。虽然原发性开角型青光眼更为常见，但原发性闭角型青光眼（PACG）更有可能导致不可逆性失明。到 2020 年，全世界将有 530 万人因 PACG 而失明。目前，PACG 的标准治疗方法是激光虹膜切开术（打开房水引流角）和药物治疗（降低眼内压）相结合的阶梯式治疗。如果这些治疗方法失败，则需要进行青光眼手术（如小梁切除术）。有人提出，由于眼睛的晶状体在导致 PACG 的机制中起着重要作用，因此早期晶状体摘除将通过打开房水引流角来改善青光眼的控制。与标准治疗相比，该手术可能减少药物和青光眼手术的需求，保持良好的视力，并提高生活质量。
EAGLE 旨在评估与标准治疗相比，早期晶状体摘除是否能改善患者报告的临床结局和成本效益。
方法/设计：EAGLE 是一项多中心实用随机试验。所有在英国和东亚的招募中心新诊断为 PACG 且年龄至少 50 岁的患者均符合入组条件。主要结局是 EQ-5D、眼内压和每获得一个质量调整生命年（QALY）的增量成本。其他结局是：视力和青光眼特异性患者报告结局、视力、视野、房角关闭、用药数量、附加手术（如小梁切除术）、卫生服务和患者的成本以及不良事件。在 3 年随访结束时，也就是试验结束时，将进行一次单一的主要分析。该分析将基于所有按随机分组（意向治疗）的参与者。将招募 400 名参与者（每组 200 名），以 5%的显著性水平和 90%的效能检测两组之间 EQ-5D 评分的差异为 0.05，以及眼内压的平均差异为 1.75mmHg。该研究将有 80%的效能检测青光眼手术率差异 15%。
ISRCTN44464607。
