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dc.contributor.authorKing, Anthony J.
dc.contributor.authorFernie, Gordon
dc.contributor.authorAzuara-Blanco, Augusto
dc.contributor.authorBurr, Jennifer M.
dc.contributor.authorGarway-Heath, Ted
dc.contributor.authorSparrow, John M.
dc.contributor.authorVale, Luke
dc.contributor.authorHudson, Jemma
dc.contributor.authorMacLennan, Graeme
dc.contributor.authorMcDonald, Alison
dc.contributor.authorBarton, Keith
dc.contributor.authorNorrie, John
dc.identifier.citationKing , A J , Fernie , G , Azuara-Blanco , A , Burr , J M , Garway-Heath , T , Sparrow , J M , Vale , L , Hudson , J , MacLennan , G , McDonald , A , Barton , K & Norrie , J 2018 , ' 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 ' , British Journal of Ophthalmology , vol. 102 , no. 7 , pp. 922-928 .
dc.identifier.otherORCID: /0000-0002-9478-738X/work/60196191
dc.descriptionThe trial is funded by a grant awarded by the Health Technology Assessment (NIHR HTA) programme (project number 12/35/38).en
dc.description.abstractBackground: 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.
dc.relation.ispartofBritish Journal of Ophthalmologyen
dc.subjectClinical trialen
dc.subjectIntraocular pressureen
dc.subjectTreatment medicalen
dc.subjectTreatment surgeryen
dc.subjectRE Ophthalmologyen
dc.subjectSensory Systemsen
dc.subjectCellular and Molecular Neuroscienceen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.titleTreatment of Advanced Glaucoma Study : a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma - study protocolen
dc.typeJournal articleen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Population and Behavioural Science Divisionen
dc.description.statusPeer revieweden

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