Document Type

Other

Disciplines

Optics, Ophthalmology, Other clinical medicine subjects, Health policy and services

Creative Commons License

CC0 1.0 Universal (CC0 1.0) Public Domain Dedication
This work is licensed under a CC0 1.0 Universal (CC0 1.0) Public Domain Dedication License.

Publication Details

CONSORT 2010 checklist of information to include when reporting a randomised trial* Myopia Outcome Study of Atropine in Children (MOSAIC): Design and Methodology

Abstract

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 (RCT) investigating the efficacy, safety and mechanisms of action of 0.01% atropine in myopia 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. Additional analyses will include the mechanisms of action of 0.01% atropine for myopia control.

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 RCT to explore the efficacy, safety and mechanisms of action of unpreserved 0.01% atropine in a predominantly white population.

DOI

https://doi.org/10.21427/3neg-gr77

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