Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations]
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, ran...
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doaj-c8ea0732c56140cca618cf5a659e16972020-11-25T04:05:57ZengF1000 Research LtdHRB Open Research2515-48262019-07-01210.12688/hrbopenres.12914.113992Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations]Saoirse McCrann0Ian Flitcroft1Niall C. Strang2Kathryn J. Saunders3Nicola S. Logan4Samantha Szeyee Lee5David A. Mackey6John S. Butler7James Loughman8Centre for Eye Research Ireland, School of Physics, Clinical and Optometric Sciences, Technological University Dublin, Ireland, Dublin, IrelandChildren’s University Hospital, Dublin, IrelandDepartment of Vision Sciences, Glasgow Caledonian University, Glasgow, UKSchool of Biomedical Sciences, University of Ulster, Coleraine, UKOptometry & Vision Science Research Group, Aston Optometry School, Aston University, Birmingham, UKCentre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), University of Western Australia, Perth, WA, AustraliaCentre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), University of Western Australia, Perth, WA, AustraliaSchool of Mathematical Sciences, Technological University Dublin, Dublin, IrelandCentre for Eye Research Ireland, School of Physics, Clinical and Optometric Sciences, Technological University Dublin, Ireland, Dublin, IrelandBackground: 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. 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 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. Trial registration: ISRCTN: ISRCTN36732601 (04/10/2017), EudraCTdatabase 2016-003340-37 (03/07/2018).https://hrbopenresearch.org/articles/2-15/v1 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Saoirse McCrann Ian Flitcroft Niall C. Strang Kathryn J. Saunders Nicola S. Logan Samantha Szeyee Lee David A. Mackey John S. Butler James Loughman |
spellingShingle |
Saoirse McCrann Ian Flitcroft Niall C. Strang Kathryn J. Saunders Nicola S. Logan Samantha Szeyee Lee David A. Mackey John S. Butler James Loughman Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] HRB Open Research |
author_facet |
Saoirse McCrann Ian Flitcroft Niall C. Strang Kathryn J. Saunders Nicola S. Logan Samantha Szeyee Lee David A. Mackey John S. Butler James Loughman |
author_sort |
Saoirse McCrann |
title |
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
title_short |
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
title_full |
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
title_fullStr |
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
title_full_unstemmed |
Myopia Outcome Study of Atropine in Children (MOSAIC): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
title_sort |
myopia outcome study of atropine in children (mosaic): an investigator-led, double-masked, placebo-controlled, randomised clinical trial protocol [version 1; peer review: 2 approved, 1 approved with reservations] |
publisher |
F1000 Research Ltd |
series |
HRB Open Research |
issn |
2515-4826 |
publishDate |
2019-07-01 |
description |
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. 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 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. Trial registration: ISRCTN: ISRCTN36732601 (04/10/2017), EudraCTdatabase 2016-003340-37 (03/07/2018). |
url |
https://hrbopenresearch.org/articles/2-15/v1 |
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