RT Journal Article
SR Electronic
T1 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
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
SP bjophthalmol-2017-310902
DO 10.1136/bjophthalmol-2017-310902
A1 Anthony J King
A1 Gordon Fernie
A1 Augusto Azuara-Blanco
A1 Jennifer M Burr
A1 Ted Garway-Heath
A1 John M Sparrow
A1 Luke Vale
A1 Jemma Hudson
A1 Graeme MacLennan
A1 Alison McDonald
A1 Keith Barton
A1 John Norrie
YR 2017
UL http://bjo.bmj.com/content/early/2017/10/26/bjophthalmol-2017-310902.abstract
AB 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.