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]

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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. 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).
Original languageEnglish
JournalHRB Open Research
Volume2
Early online date23 Jul 2019
DOIs
Publication statusPublished - 25 Sep 2019

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Peer Review
Myopia
Clinical Protocols
Atropine
Placebos
Research Personnel
Outcome Assessment (Health Care)
Safety
Ophthalmic Solutions
Arm
Randomized Controlled Trials
Degenerative Myopia
Population
Mydriatics
Withholding Treatment
Refractive Errors
Random Allocation
Clinical Trials

Keywords

  • myopia
  • atropine
  • myopia progression
  • myopia control

Cite this

@article{2875f4b1faf6445993d059cb2a4cce59,
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]",
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. 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).",
keywords = "myopia, atropine, myopia progression, myopia control",
author = "Niall Strang",
note = "Acceptance requested - author confirmed this platform is unusual in that the article is published before peer-review (email in SAN). Asked author to contact us when peer-review occurs. ET 30/7/19 OA article Article has 2 x DOIs relating to 2 different pub dates on the publisher webpage and 2 x published dates. Recorded as EPub and Published dates. ET",
year = "2019",
month = "9",
day = "25",
doi = "10.12688/hrbopenres.12914.1",
language = "English",
volume = "2",

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T1 - 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]

AU - Strang, Niall

N1 - Acceptance requested - author confirmed this platform is unusual in that the article is published before peer-review (email in SAN). Asked author to contact us when peer-review occurs. ET 30/7/19 OA article Article has 2 x DOIs relating to 2 different pub dates on the publisher webpage and 2 x published dates. Recorded as EPub and Published dates. ET

PY - 2019/9/25

Y1 - 2019/9/25

N2 - 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).

AB - 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).

KW - myopia

KW - atropine

KW - myopia progression

KW - myopia control

U2 - 10.12688/hrbopenres.12914.1

DO - 10.12688/hrbopenres.12914.1

M3 - Article

VL - 2

ER -