Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol

McCrann, Saoirse, Flitcroft, Ian, Strang, Niall C., Saunders, Kathryn J., Logan, Nicola S., Lee, Samantha Szeyee, Mackey, David A., Butler, John S. and Loughman, James (2019). Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol. HRB Open Research, 2 (15),

Abstract

Background: The Myopia Outcome Study of Atropine in Children (MOSAIC) aims to explore the efficacy, safety, acceptability and mechanisms of action of 0.01% unpreserved 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 for managing progression of myopia. During Phase 1 of the trial, 250 children aged 6-16 years with progressive myopia instil eye drops once nightly in both eyes from randomisation to month 24. From month 24 to 36 participants are re-randomised in Phase 2 of the trial, into continued 0.01% atropine, and washout, at 1:1 ratio for those participants initially randomised to the intervention arm (n=167), during which any potential rebound effects on cessation 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 in both eyes 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 cycloplegic 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. Conclusions: The generalisability of results from previous clinical trials investigating atropine for myopia control is limited by the predominantly Asian ethnicity of previous study populations. MOSAIC is the first RCT to explore the efficacy, safety and mechanisms of action of unpreserved 0.01% atropine in a predominantly White population.

Publication DOI: https://doi.org/10.12688/hrbopenres.12914.2
Divisions: Life & Health Sciences > Optometry
Life & Health Sciences > Ophthalmic Research Group
Life & Health Sciences > Vision, Hearing and Language
Life & Health Sciences
Additional Information: © 2019 McCrann S et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Full Text Link:
Related URLs: https://hrbopen ... g/articles/2-15 (Publisher URL)
PURE Output Type: Article
Published Date: 2019-09-25
Accepted Date: 2019-07-23
Authors: McCrann, Saoirse
Flitcroft, Ian
Strang, Niall C.
Saunders, Kathryn J.
Logan, Nicola S. ( 0000-0002-0538-9516)
Lee, Samantha Szeyee
Mackey, David A.
Butler, John S.
Loughman, James

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