Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

Background: Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients.
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 multicentre 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 randomised 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 measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution 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 glaucoma profile instrument will be estimated.
Results: The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years.
Conclusions: Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.
Trial Registration Number: ISRCTN56878850, Pre-results.
Competing Interests: Competing interests: TAGS is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 12/35/38). JMB, GM, AM and JMS report grants from NIHR Health Technology Assessment Programme during the conduct of the study. LV reports grants from NIHR HTA Programme during the conduct of the study; and membership of the NIHR Health Technology Assessment Programme and a director of the NIHR Research Design Service. JN reports grants from NIHR HTA during the conduct of the study; personal fees from NIHR Editors Board, other from NIHR HTA General Board, outside the submitted work.
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