Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol

AUGUSTO AZUARA-BLANCO, NICOLA LOGAN, Niall Strang, Kathryn J Saunders, PETER ALLEN, RUTH WEIR, PAUL DOHERTY, CATHERINE ADAMS, EVIE GARDNER, RUTH HOGG, MARGARET MCFARLAND, JENNIFER PRESTON, REJINA VERGHIS, JAMES LOUGHMAN, IAN FLITCROFT, DAVID MACKEY, SAMANTHA LEE, CHRISTOPHER HAMMOND, NATHAN CONGDON, CLARKE MIKE

Research output: Contribution to journalArticle

Abstract

Background/Aims: To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low dose atropine (0.01%) eye drops for reducing progression of myopia in UK children.
Methods: Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 diopters or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for two years and attend a research centre every six months. The vehicle and preservative will be the same in both study arms. The primary outcome is spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia at two years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y), and tolerability at two years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorio-retinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.
Conclusions: CHAMP-UK will be the first randomised trial reporting outcomes of low-dose atropine eye drops for children with myopia in a UK population.
LanguageEnglish
JournalBritish Journal of Ophthalmology
Publication statusAccepted/In press - 5 Oct 2019

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Ophthalmic Solutions
Myopia
Atropine
Randomized Controlled Trials
Placebos
Refractive Errors
Visual Acuity
Biometry
Ciliary Body
Withholding Treatment
Anterior Chamber
Iris
Pupil
Clinical Protocols
Double-Blind Method
Reading
Hypersensitivity
Arm
Color
Quality of Life

Keywords

  • MYOPIA
  • Clinical trial
  • LOW DOSE ATROPINE
  • CHILD HEALTH (PAEDIATRICS)

Cite this

AZUARA-BLANCO, AUGUSTO ; LOGAN, NICOLA ; Strang, Niall ; Saunders, Kathryn J ; ALLEN, PETER ; WEIR, RUTH ; DOHERTY, PAUL ; ADAMS, CATHERINE ; GARDNER, EVIE ; HOGG, RUTH ; MCFARLAND, MARGARET ; PRESTON, JENNIFER ; VERGHIS, REJINA ; LOUGHMAN, JAMES ; FLITCROFT, IAN ; MACKEY, DAVID ; LEE, SAMANTHA ; HAMMOND, CHRISTOPHER ; CONGDON, NATHAN ; MIKE, CLARKE. / Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol. In: British Journal of Ophthalmology. 2019.
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abstract = "Background/Aims: To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low dose atropine (0.01{\%}) eye drops for reducing progression of myopia in UK children.Methods: Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 diopters or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for two years and attend a research centre every six months. The vehicle and preservative will be the same in both study arms. The primary outcome is spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia at two years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y), and tolerability at two years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorio-retinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.Conclusions: CHAMP-UK will be the first randomised trial reporting outcomes of low-dose atropine eye drops for children with myopia in a UK population.",
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author = "AUGUSTO AZUARA-BLANCO and NICOLA LOGAN and Niall Strang and Saunders, {Kathryn J} and PETER ALLEN and RUTH WEIR and PAUL DOHERTY and CATHERINE ADAMS and EVIE GARDNER and RUTH HOGG and MARGARET MCFARLAND and JENNIFER PRESTON and REJINA VERGHIS and JAMES LOUGHMAN and IAN FLITCROFT and DAVID MACKEY and SAMANTHA LEE and CHRISTOPHER HAMMOND and NATHAN CONGDON and CLARKE MIKE",
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AZUARA-BLANCO, AUGUSTO, LOGAN, NICOLA, Strang, N, Saunders, KJ, ALLEN, PETER, WEIR, RUTH, DOHERTY, PAUL, ADAMS, CATHERINE, GARDNER, EVIE, HOGG, RUTH, MCFARLAND, MARGARET, PRESTON, JENNIFER, VERGHIS, REJINA, LOUGHMAN, JAMES, FLITCROFT, IAN, MACKEY, DAVID, LEE, SAMANTHA, HAMMOND, CHRISTOPHER, CONGDON, NATHAN & MIKE, CLARKE 2019, 'Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol', British Journal of Ophthalmology.

Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol. / AZUARA-BLANCO, AUGUSTO; LOGAN, NICOLA; Strang, Niall; Saunders, Kathryn J; ALLEN, PETER; WEIR, RUTH; DOHERTY, PAUL; ADAMS, CATHERINE; GARDNER, EVIE; HOGG, RUTH; MCFARLAND, MARGARET; PRESTON, JENNIFER; VERGHIS, REJINA; LOUGHMAN, JAMES; FLITCROFT, IAN; MACKEY, DAVID; LEE, SAMANTHA; HAMMOND, CHRISTOPHER; CONGDON, NATHAN; MIKE, CLARKE.

In: British Journal of Ophthalmology, 05.10.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Low-dose (0.01%) atropine eye drops to reduce progression of myopia in children: a multi-centre placebo-controlled randomised trial in the United Kingdom (CHAMP-UK) – study protocol

AU - AZUARA-BLANCO, AUGUSTO

AU - LOGAN, NICOLA

AU - Strang, Niall

AU - Saunders, Kathryn J

AU - ALLEN, PETER

AU - WEIR, RUTH

AU - DOHERTY, PAUL

AU - ADAMS, CATHERINE

AU - GARDNER, EVIE

AU - HOGG, RUTH

AU - MCFARLAND, MARGARET

AU - PRESTON, JENNIFER

AU - VERGHIS, REJINA

AU - LOUGHMAN, JAMES

AU - FLITCROFT, IAN

AU - MACKEY, DAVID

AU - LEE, SAMANTHA

AU - HAMMOND, CHRISTOPHER

AU - CONGDON, NATHAN

AU - MIKE, CLARKE

PY - 2019/10/5

Y1 - 2019/10/5

N2 - Background/Aims: To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low dose atropine (0.01%) eye drops for reducing progression of myopia in UK children.Methods: Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 diopters or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for two years and attend a research centre every six months. The vehicle and preservative will be the same in both study arms. The primary outcome is spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia at two years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y), and tolerability at two years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorio-retinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.Conclusions: CHAMP-UK will be the first randomised trial reporting outcomes of low-dose atropine eye drops for children with myopia in a UK population.

AB - Background/Aims: To report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low dose atropine (0.01%) eye drops for reducing progression of myopia in UK children.Methods: Multicentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6-12 years with myopia of -0.50 diopters or worse in both eyes. We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for two years and attend a research centre every six months. The vehicle and preservative will be the same in both study arms. The primary outcome is spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia at two years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y), and tolerability at two years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorio-retinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.Conclusions: CHAMP-UK will be the first randomised trial reporting outcomes of low-dose atropine eye drops for children with myopia in a UK population.

KW - MYOPIA

KW - Clinical trial

KW - LOW DOSE ATROPINE

KW - CHILD HEALTH (PAEDIATRICS)

M3 - Article

JO - British Journal of Ophthalmology

T2 - British Journal of Ophthalmology

JF - British Journal of Ophthalmology

SN - 0007-1161

ER -