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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
  1. Augusto Azuara-Blanco1,
  2. Nicola Logan2,
  3. Niall Strang3,
  4. Kathryn Saunders4,
  5. Peter M Allen5,
  6. Ruth Weir6,
  7. Paul Doherty6,
  8. Catherine Adams6,
  9. Evie Gardner6,
  10. Ruth Hogg1,
  11. Margaret McFarland7,
  12. Jennifer Preston8,
  13. Rejina Verghis6,
  14. James J Loughman9,
  15. Ian Flitcroft10,
  16. David A Mackey11,
  17. Samantha Sze-Yee Lee11,
  18. Christopher Hammond12,
  19. Nathan Congdon1,13,14,
  20. Mike Clarke1,6
  1. 1Centre for Public Health, Queen's University Belfast School of Medicine Dentistry and Biomedical Sciences, Belfast, UK
  2. 2School of Life & Health Sciences, Aston University, Birmingham, UK
  3. 3Department of Vision Sciences, Glasgow Caledonian University, Glasgow, UK
  4. 4School of Biomedical Sciences, Ulster University, Coleraine, UK
  5. 5Department of Optometry and Ophthalmic Dispensing, Anglia Ruskin University, Cambridge, UK
  6. 6NICTU, Belfast Health and Social Care Trust, Belfast, UK
  7. 7Department of Pharmacy, Belfast Health and Social Care Trust, Belfast, UK
  8. 8Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  9. 9Optometry Department, Dublin Institute of Technology, Dublin, Ireland
  10. 10Department of Ophthalmology, Childrens University Hospital, Dublin, Ireland
  11. 11Centre for Ophthalmology and Visual Science, University of Western Australia, Lions Eye Institute, Perth, Western Australia, Australia
  12. 12Department of Twin Research and Genetic Epidemiology, King’s College London, London, UK
  13. 13Department of Preventive Ophthalmology, Zhongshan Ophthalmic Center, Guangdong, China
  14. 14Orbis International, New York, United States
  1. Correspondence to Professor Augusto Azuara-Blanco, Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK; a.azuara-blanco{at}qub.ac.uk

Abstract

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.

  • treatment medical
  • optics and refraction
  • drugs
  • clinical trial
  • child health (paediatrics)
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Footnotes

  • Twitter @drNicolaLogan, @ruth_hogg

  • Collaborators Annegret Dahlmann-Noor.

  • Funding The trial is funded by a grant awarded by National Institute for Health Research Efficacy and Mechanism Evaluation (project 15/48/59). CHAMP-UK is registered (ISRCTN99883695, NCT03690089). The Belfast Health and Social Care Trust sponsors the trial and provides the necessary trial insurance.

  • Competing interests NL: research funding from CooperVision, Essilor and Zeiss.

  • Patient consent for publication Not required.

  • Ethics approval CHAMP-UK has been reviewed and approved by a Research Ethics Committee (18/NI/0164).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on request.

  • Author note Acronym: The Childhood Atropine for Myopia Progression in the UK study (CHAMP-UK).

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