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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: A multicentre placebo-controlled randomised trial in the UK (CHAMP-UK) - Study protocol
British Journal of Ophthalmology, Volume 104, No. 7, Year 2020
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Description
Background/aims To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children. Methods Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 dioptres or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms. The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events. Conclusions The Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population. Trial registration number ISRCTN99883695, NCT03690089. © 2020 BMJ Publishing Group. All rights reserved.
Authors & Co-Authors
Azuara-Blanco, Augusto
United Kingdom, Belfast
Queen's University Belfast
Logan, Nicola S.
United Kingdom, Birmingham
Aston University
Saunders, Kathryn J.
United Kingdom, Coleraine
Ulster University
Allen, Peter M.
United Kingdom, Cambridge
Anglia Ruskin University
Doherty, Paul
United Kingdom, Belfast
Belfast Health and Social Care Trust
Adams, Catherine
United Kingdom, Belfast
Belfast Health and Social Care Trust
Gardner, Evie
United Kingdom, Belfast
Belfast Health and Social Care Trust
Hogg, Ruth E.
United Kingdom, Belfast
Queen's University Belfast
Preston, Jennifer
United Kingdom, Liverpool
University of Liverpool
Loughman, James J.
Ireland, Dublin
Technological University Dublin
Flitcroft, Daniel Ian
Ireland, Dublin
Temple Street, Children’s University Hospital
Mackey, David A.
Australia, Perth
The University of Western Australia
Hammond, Christopher J.
United Kingdom, London
King's College London
Congdon, Nathan Greenleaf
United Kingdom, Belfast
Queen's University Belfast
China, Guangzhou
Zhongshan Ophthalmic Center
United States, New York
Orbis International
Clarke, Michael J.
United Kingdom, Belfast
Queen's University Belfast
United Kingdom, Belfast
Belfast Health and Social Care Trust
Statistics
Citations: 33
Authors: 15
Affiliations: 13
Identifiers
Doi:
10.1136/bjophthalmol-2019-314819
ISSN:
00071161
Research Areas
Disability
Health System And Policy
Maternal And Child Health
Study Design
Cross Sectional Study