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.
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.
| Original language | English |
|---|---|
| Journal | BRITISH JOURNAL OF OPHTHALMOLOGY |
| Early online date | 25 Oct 2019 |
| Publication status | Published online - 25 Oct 2019 |
Keywords
- MYOPIA
- Clinical trial
- LOW DOSE ATROPINE
- CHILD HEALTH (PAEDIATRICS)
