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

Abstract

Background/aimsTo 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.MethodsMulticentre, 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.ConclusionsThe 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 numberISRCTN99883695, NCT03690089.

Is optometry ready for myopia control? Education and other barriers to the treatment of myopia

“…Studies have also indicated bifocal and progressive addition spectacle lenses can also slow the progression of myopia in children with near-point esophoria and larger accommodative lags 15 – 17 . Low dose atropine is not readily available as a licensed product in Europe but is accessible through clinical trials, with the recruitment of trial participants dependent on Optometrist referrals 18 – 20 . A number of contact lens options for managing myopia are also commercially available in Europe and are reported to slow myopia progression by approximately 30% to 60% 13 .…”

Is optometry ready for myopia control? Education and other barriers to the treatment of myopia

“…There is a scarcity of published literature that examines the possible reasons for the very limited uptake of active myopia management. A search of various databases including MEDLINE, EMBASE, Google Scholar, Scopus, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov during the preparatory stages of this study revealed only three research papers and a round table discussion that explored the knowledge and attitudes of eye care professionals toward myopia and its control [13][14][15][16] . Rather than a lack of evidence for efficacy, the barriers appear largely attitudinal; eye-care practitioners consider the information required to implement myopia control techniques to be lacking, as well as reporting concerns about the safety, cost and availability of such measures 13 .…”

The Combined Effect of Low-dose Atropine with Orthokeratology in Pediatric Myopia Control: Review of the Current Treatment Status for Myopia

“…Efficacy in terms of axial length changes is presented in Table 1. Almost all studies studied Asian populations and therefore evidence on European and other ethnicities is limited [33,34] although there appears to be a difference in efficacy between white and Asian children [34] that may be justified by the greater progression of myopia in Asian children and not by the efficacy of the drug. However, dosing guidelines and populations have not been well established in some of the studies consulted; therefore, further investigation is required.…”