Aim: To compare clinical and cost effectiveness of primary medical management compared with primary surgery for people presenting with advanced open angle glaucoma (OAG).
Methods: Design: A prospective, pragmatic multi-centre randomised controlled trial (RCT).
Setting: Twenty seven UK hospital eye services.
Participants: Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss.
Intervention: Participants will be randomized to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).
Main Outcome Measures: The primary outcome is vision-related quality of life (QoL) measured by the National Eye Institute - Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 (HUI-3)] and glaucoma related health status [Glaucoma Utility Index (GUI)], patient experience, visual field measured by mean deviation value, LOGmar 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 GPI will be estimated.
Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in a patients presenting with advanced glaucoma in terms of patient reported health and visual function, clinical outcomes and incremental cost per QALY at two-years.
Conclusions: TAGS will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.