Nottingham University Hospital, Nottingham, United Kingdom.
Health Services Research Unit, Centre for Healthcare Randomized Trials, University of Aberdeen, Aberdeen, United Kingdom.
Am J Ophthalmol. 2020 May;213:186-194. doi: 10.1016/j.ajo.2020.01.026. Epub 2020 Mar 13.
To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study).
Pragmatic randomized control trial (RCT).
Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI).
A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA "severe" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3.
TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.
报告 TAGS（高级青光眼治疗研究）入组患者的基线特征。
实用随机对照试验（RCT）。
招募至少一只眼新诊断为高级青光眼的参与者。参与者为开角型青光眼患者，至少一只眼符合 Hodapp-Parrish-Anderson（HPA）标准定义的严重缺陷的高级青光眼。参与者被随机分配接受初级增强小梁切除术或初级药物治疗。当双眼都符合条件时，双眼均接受相同的干预措施，分析的指数眼为视野平均缺损（MD）较轻的眼。主要观察指标为 HPA 分类定义的视野特征；临床特征；生活质量，通过国家眼科研究所视觉功能问卷 25（VFQ-25）、欧洲质量五维（EQ-5D 5L）、健康效用指数-3（HUI-3）和青光眼量表（GPI）进行测量。
共招募了 453 名患者。指数眼的平均视野 MD 为-15.0 dB ± 6.3，非指数眼为-6.2 dB。在基线时（HPA“严重”分类），超过 70%的参与者的 MD <-12.00 dB，近 90%的参与者在 1%水平有超过 20 个点的缺陷。指数眼的平均 LogMAR 视力为 0.2 ± 0.3。
TAGS 是第一项比较医疗与手术治疗在公共资助的卫生服务中出现的高级开角型青光眼患者的 RCT。该研究将提供临床、健康相关生活质量和经济学结果，为未来治疗高级青光眼患者提供信息。
