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Objective To 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. Design Pragmatic multicentre randomised controlled trial. Setting 27 secondary care glaucoma departments in the UK. Participants 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. Interventions Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) Main outcome measures Primary 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. Results At 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 Conclusion Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. Trial registration Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850 .

Nottingham University Hospitals NHS Trust sponsored the trial and provided the necessary trial insurance. The trial was funded by a grant from the National Institute for Health Research Health Technology Assessment (NIHR HTA) program (project number 12/35/38), trial registration number ISRCTN56878850. Disclaimer: The views expressed are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR or the Department of Health. Ethics approval: the study adhered to the tenets of the Declaration of Helsinki and the principles of Good Clinical Practice and was carried out in accordance with all applicable regulatory guidance, including but not limited to the Research Governance Framework. TAGS′ protocol and patient-facing documentation were prospectively reviewed and approved by the Derby 1 Research Ethics Committee (ref number 13/EM/00395). Local NHS Research and Development (R&D) approvals were obtained prior to commencement of the trial at the participating sites. An independent data and safety monitoring committee oversees. Purpose To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). Design Pragmatic randomized control trial (RCT). Methods 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). Results 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