Nottingham University Hospital, Nottingham, United Kingdom.
Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Aberdeen, United Kingdom.
Ophthalmology. 2024 Jul;131(7):759-770. doi: 10.1016/j.ophtha.2024.01.007. Epub 2024 Jan 9.
To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma.
Multicenter randomized controlled trial.
Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management.
Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years.
The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety.
At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare.
At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
在患有晚期青光眼的患者中，比较原发性小梁切除术与药物治疗在生活质量（QoL）、临床效果和安全性方面的优劣。
多中心随机对照试验。
2014 年 6 月 3 日至 2017 年 5 月 31 日期间，英国 27 家二级保健青光眼科室共招募了 453 名新诊断为晚期开角型青光眼的成年人（Hodapp 分类），他们的至少 1 只眼患有该疾病。227 名患者被分配接受小梁切除术，226 名患者被分配接受药物治疗。
参与者按 1:1 的比例随机分为米诺环素 C 增强型小梁切除术组或递增药物治疗组，以眼压（IOP）降低滴注为主要干预措施，并随访 5 年。
主要结局是使用 25 项视觉功能问卷（VFQ-25）在 5 年时测量的视力特异性 QoL。次要结局是一般健康状况、青光眼相关 QoL、临床效果（IOP、视野和视力）和安全性。
5 年后，小梁切除术组和药物治疗组的平均 VFQ-25 评分分别为 83.3±15.5 和 81.3±17.5，平均差异为 1.01（95%置信区间[CI]，-1.99 至 4.00；P=0.51）。平均 IOP 分别为 12.07±5.18mmHg 和 14.76±4.14mmHg，平均差异为-2.56（95%CI，-3.80 至-1.32；P<0.001）。用平均视野缺损测量的青光眼严重程度分别为-14.30±7.14dB 和-16.74±6.78dB，平均差异为 1.87（95%CI，0.87-2.87dB；P<0.001）。小梁切除术组有 115 名（52.2%）患者和药物治疗组有 124 名（57.9%）患者发生了安全性事件（相对风险，0.92；95%CI，0.72-1.19；P=0.54）。严重不良事件较为罕见。
5 年后，高级青光眼治疗研究表明，原发性小梁切除术在降低眼压和预防疾病进展方面比原发性药物治疗更有效，在晚期疾病患者中具有相似的安全性。
