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.
Anthony J King, Gordon Fernie, Augusto Azuara-Blanco, Jennifer M Burr, Ted Garway-Heath, John M Sparrow, Luke Vale, Jemma Hudson, Graeme MacLennan, Alison McDonald, Keith Barton, John Norrie
Summary
Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.
Abstract
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
: 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.
Keywords
More by Anthony J King
View full profile →Exploring literature-based definitions of hypotony following glaucoma filtration surgery and the impact on clinical outcomes.
Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study.
Survey of glaucoma surgical preferences and post-operative care in the United Kingdom.
Top Research in Quality of Life
Browse all →Neuroprotective strategies for retinal disease.
Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma.
The Association Between Glaucoma, Anxiety, and Depression in a Large Population.
In the Knowledge Library
Discussion
Comments and discussion will appear here in a future update.