Baseline characteristics of participants in the Treatment of Advanced Glaucoma Study (TAGS): A multicentre randomised controlled trial.

PURPOSE: To report the baseline characteristics of participants enrolled in the Treatment of Advanced Glaucoma Study (TAGS) DESIGN: Pragmatic randomised control trial (RCT). PARTICIPANTS: Patients with open angle glaucoma presenting with advanced glaucoma in at least one eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria of severe defect. METHODS: Participants with newly diagnosed advanced glaucoma in at least one eye were recruited. 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 deviation (MD). MAIN OUTCOME MEASURES: Visual field profile defined by the HPA classification, clinical characteristics, Quality of life measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3) and Glaucoma Profile Instrument (GPI) RESULTS: Four hundred and fifty-three patients were recruited. The mean visual field MD was -15.0dB (SD 6.3) in the index eye and -6.2dB in the non-index eye. Of index eyes (HPA 'severe' classification) at baseline, over 70% had a mean deviation < -12.00dB 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 (SD 0.3), CONCLUSIONS: TAGS is the first RCT to compare medical and surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. It will provide clinical, health related quality of life and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.