Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS)

• Published in: BMJ (Online) Vol. 373; p. n1014
• Main Authors: King, Anthony J, Hudson, Jemma, Fernie, Gordon, Kernohan, Ashleigh, Azuara-Blanco, Augusto, Burr, Jennifer, Homer, Tara, Shabaninejad, Hosein, Sparrow, John M, Garway-Heath, David, Barton, Keith, Norrie, John, McDonald, Alison, Vale, Luke, MacLennan, Graeme
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 12.05.2021; BMJ Publishing Group Ltd
• Subjects: Acuity; Adverse events; Cataracts; Eye surgery; Glaucoma; Medical treatment; Mitomycin C; Patients; Pressure; Quality of life; Questionnaires; Safety; Standard deviation; Statistical analysis; Surgeons; Surgical outcomes; Visual field; Visual perception; United Kingdom > UK; North America; Europe
• ISSN: 1756-1833; 0959-8138; 1756-1833
• DOI: 10.1136/bmj.n1014

AbstractObjectiveTo 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.DesignPragmatic multicentre randomised controlled trial.Setting27 secondary care glaucoma departments in the UK.Participants453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.InterventionsMitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226)Main outcome measuresPrimary 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.ResultsAt 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.ConclusionPrimary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.Trial registrationHealth Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.