Department of Ophthalmology, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, University of Aberdeen, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
Br J Ophthalmol. 2018 Jul;102(7):922-928. doi: 10.1136/bjophthalmol-2017-310902. Epub 2017 Oct 26.
Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients.
To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG).
: A prospective, pragmatic multicentre randomised controlled trial (RCT).
Twenty-seven UK hospital eye services.
Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss.
Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).
The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated.
The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years.
Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.
ISRCTN56878850, Pre-results.
晚期青光眼的表现是导致终身失明的主要危险因素。在诊断时进行有效的干预，预计可以将这组患者进一步视力丧失的风险降到最低。
比较原发性医学治疗与原发性手术治疗晚期开角型青光眼（OAG）患者的临床效果和成本效益。
前瞻性、实用的多中心随机对照试验（RCT）。
英国 27 家医院眼科服务机构。
根据视野丧失的 Hodapp-Parish-Anderson 分类，440 名患有晚期 OAG 的患者。
参与者将被随机分配到药物治疗或增强型小梁切除术组（根据中心和双眼均有晚期疾病进行 1:1 分配）。
主要结局是 24 个月时通过国家眼科研究所视觉功能问卷-25 测量的与视力相关的生活质量。次要结局包括通用 EQ-5D-5L、健康效用指数-3 和青光眼相关健康状况（青光眼效用指数）、患者体验、平均偏差值测量的视野、对数平均分辨率视力、眼内压、不良事件、驾驶标准和失明认证资格。基于 EQ-5D-5L 和青光眼概况仪，将估计每增加一个质量调整生命年（QALY）的增量成本。
该研究将报告在 2 年时，根据患者报告的健康和视觉功能、临床结局和每增加一个 QALY 的增量成本，比较药物治疗与增强型小梁切除术治疗晚期青光眼患者的相对有效性和成本效益。
晚期青光眼治疗研究将是第一项从晚期青光眼患者角度报告结果的 RCT。
ISRCTN56878850，预结果。
