A daily eye drop containing a low dose of atropine could slow the worsening of short-sightedness in children by at least 40%. Myopia, or short-sightedness, is becoming more common in children worldwide. It typically worsens as a child grows, often requiring stronger glasses every year. High levels of myopia also increase the lifelong risk of serious eye conditions such as retinal detachment and glaucoma. While atropine eye drops have shown promise in slowing myopia progression, their long-term safety and effectiveness in a UK population have not been tested in a large, rigorous trial. This trial will recruit 289 children aged 6 to 12, giving them either 0.01% atropine drops or a placebo once daily for two years. The researchers will measure changes in refractive error and axial length—the physical elongation of the eyeball that drives myopia—every six months. They will also monitor side effects, adherence, and long-term safety five years after treatment ends. If the drops prove effective and safe, they could offer a simple, non-invasive way to reduce the need for increasingly strong glasses in children and lower their future risk of sight-threatening eye disease.
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DESIGN: Multicentre, prospective, double-masked, randomized (2:1) placebo-controlled trial of topical 0.01% atropine eye drops. POPULATION: Children with myopia. INCLUSION CRITERIA: 6-12 years of age with myopia of -0.5 dioptres (D) or higher (spherical equivalent refractive error) and best corrected visual acuity (BCVA) of 0.20 logMAR or better in both eyes. INTERVENTION: Once daily 0.01% atropine eye drops to both eyes for two years. COMPARATOR: placebo eye drops. OUTCOMES: Primary outcome is change in cycloplegic spherical equivalent refractive error measured by autorefraction at 2 years (the average of both eyes). Secondary outcomes: BCVA, near VA, pupil diameter, adverse events, tolerability. Mechanistic evaluation: central and peripheral axial length, position of the lens, accommodation, peripheral retinal defocus, and macular chorio-retinal thickness. ASSESSMENTS: At baseline, and every 6 months until month 24, we will assess cycloplegic refractive error (auto-refractometer) and adverse events. At 12 and 24 months: BCVA (ETDRS), near VA (near ETDRS), pupil diameter (autorefractor), lens position (laser biometer), central and peripheral axial length (laser biometer), peripheral refractive error (auto-refractometer), and foveal chorio-retinal thickness (optical coherence tomography). Adherence with eye drops will be monitored with compliance electronic monitoring and by weighing of returned bottles every three months. Tolerability will be self-reported with a 4-level scale. Spectacle use, change in spectacle correction and time spent in near work and outdoor activity will be monitored. Long-term safety will be investigated via questionnaires to participants and optometrists at 5 years after randomisation. SAMPLE SIZE: Atropine eye drops will reduce myopia progression by at least 40%. Based on a SD=0.7 and accounting for clustering using an ICC=0.9 and variance inflation factor of 1.9 results in 97 children per group. Considering a dropout rate of 15% and a 10% rate of Chinese participants we will need 289 children (193 atropine, 75 placebo, VIF 1.9) to detect difference in a non-Chinese population with 90% power. STATISTICAL ANALYSIS: Analysis will be based on the intention to treat principle. A p-value of <0.05 will be considered statistically significant. For the primary analysis, endpoints from both eyes will be pooled in combined analysis using generalised estimating equations (GEE) to allow for the correlation between eyes within participant. Difference in myopia progression and other continuous outcomes between groups will also be tested for significance using independent t-test. Analysis of covariance will be performed to adjust for baseline characteristics. Fisher’s exact test will be used to test the difference in the proportions between the groups for the categorical variables. Exploratory subgroup analyses will be performed on the primary outcome using 99% confidence intervals and interaction terms (treatment group by subgroup) according to age and ethnicity. DURATION OF STUDY AND TIMELINE: Overall trial duration will be 48 months. 6 months: ethics approval and study set up; 15 months: recruitment; 24 months: treatment; 3 months: analysis and reporting. Including the long-term safety evaluation the duration is 84 months. EXPECTED RECRUITMENT RATE: 4 or 5 patients per month in each of 4 research centres, will be recruited through optometric practices from which we have confirmed support.
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