Myopia Outcome Study of Atropine in Children (MOSAIC): Design and Methodology

Purpose The Myopia Outcome Study of Atropine in Children (MOSAIC) aims to explore the efficacy, safety, acceptability and mechanisms of action of 0.01% atropine for myopia control in a European population. Methods MOSAIC is an investigator-led, double-masked, placebo-controlled, randomised clinical trial investigating the efficacy, safety and mechanisms of action of 0.01% atropine eyedrops in myopic progression management. During phase 1 of the trial, 250 children aged 6-16 years with progressive myopia apply eye drops once nightly in both eyes from randomisation to month 24. No treatment is given during phase 2 from month 24 to 36 (washout period) for those participants initially randomised to the intervention arm (n=167), during which any potential rebound effects on termination of treatment will be monitored. All participants initially assigned to the placebo (n=83) crossover to the intervention arm of the study for phase 2, and from month 24 to 36, instil 0.01% atropine eye drops once nightly. Further treatment and monitoring beyond 36 months is planned (phase 3) and will be designed dependent on the outcomes of phase 1. Results The primary outcome measure is spherical equivalent refractive error progression at 24 months. Secondary outcome measures include axial length change as well as the rebound, safety and acceptability profile of 0.01% atropine in a Caucasian population. Additional analyses will address questions of the mechanism of action of atropine. Conclusion The generalisability of results from previous clinical trials investigating atropine as a mechanism for myopia control is limited by the ethnic make-up of the study populations, which were predominantly Asian. MOSAIC is the first appropriately powered placebo-controlled study to investigate the efficacy, safety and mechanisms of action of unpreserved 0.01% atropine in a predominantly Caucasian population. The aim of this study is to address several significant unanswered questions that exist in relation to myopia control involving 0.01% atropine