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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

King, AJ; Fernie, G; Azuara-Blanco, A; Burr, JM; Garway-Heath, T; Sparrow, JM; Vale, L; ... Norrie, J; + view all (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 , 102 (7) pp. 922-928. 10.1136/bjophthalmol-2017-310902. Green open access

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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 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.

Type: Article
Title: 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
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bjophthalmol-2017-310902
Language: English
Additional information: This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Keywords: Science & Technology, Life Sciences & Biomedicine, Ophthalmology, glaucoma, treatment medical, intraocular pressure, clinical trial, treatment surgery, QUALITY-OF-LIFE, OPEN-ANGLE GLAUCOMA, VISUAL-FIELD LOSS, COLLABORATIVE INITIAL GLAUCOMA, NORMAL-TENSION GLAUCOMA, INTRAOCULAR-PRESSURE, OCULAR HYPERTENSION, ECONOMIC-EVALUATION, SURGERY, VISION
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Ophthalmology
URI: https://discovery.ucl.ac.uk/id/eprint/10056706
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