|Low-dose atropine eye drops to reduce progression of myopia in children: a multi-centre placebo controlled randomised trial in the United Kingdom (CHAMP UK)
Recruitment Target 289 Date Open to Recruitment May 2019 Recruitment 289 Date Closed to Recruitment February 2022
Trial Design Multicentre, randomised, double-masked, placebo-controlled superiority trial.
STUDY POPULATION: Children aged 6-12 years with myopia of -0.50 diopters (D) or greater in both eyes.
RANDOMISATION PROCEDURES: All eligible children will be randomised and allocated a unique participant ID number via sealedenvelope.com. Randomisation will be minimised by centre, ethnic background (white/non-white) and severity of myopia in the eye with more severe myopia (less than -3D versus -3D or greater). The unit of randomisation will be the participant (not the eye).
The primary and safety outcomes will be measured every six months during the treatment period. The mechanistic evaluations will take place at 12 and 24 months.
Study Aim Aim: to evaluate the efficacy and safety of low dose atropine (0.01%) eye drops to reduce progression of myopia in children.
The primary objective is:
– to evaluate the efficacy of 0.01% atropine eye drops to reduce the progression of myopia in children after 24 months of treatment.
The secondary objectives are:
– to evaluate the safety, side effects and tolerability of low dose atropine eye drops in terms of difficulties with near vision and reading, local discomfort and stinging of eye drops, photophobia, and occurrence of allergic reactions
– to determine the mechanism of action of atropine eye drops. Specifically, we will evaluate if atropine has an effect on central axial length of the eye, position of the lens, peripheral retinal defocus and use of spectacle correction.
The exploratory objective is:
– to explore the influence of other factors in the progression of myopia, including accommodation, chorio-retinal thickness at the macula, peripheral axial length hours of outdoor activity, iris colour, ethnicity, and family history.
Chief Investigator Professor Augusto Azuara-Blanco, Queen’s University Belfast
Sponsor & Funder
Sponsor Belfast Health and Social Care Trust Funder National Institute for Health and Care Research
Efficacy and Mechanism Evaluation (15/48/59)https://fundingawards.nihr.ac.uk/award/15/48/59