- Design
- Double-masked randomised trial, 9 US sites, 24 months
- Population
- 159 children aged 6-12 with myopia -0.75 to -4.50 D
- Primary outcome
- Change in cycloplegic refraction and axial length
- Effect
- SER -0.25 vs -0.90 D (difference 0.64 D, 0.50-0.79); AL 0.21 vs 0.45 mm
In this double-masked randomised trial at nine US sites, 159 children aged 6-12 with myopia of -0.75 to -4.50 D were allocated to spectacle lenses with highly aspherical lenslets (HAL) or single-vision lenses; 135 completed 24 months.
Cycloplegic refraction progressed by 0.25 D with HAL and 0.90 D with single-vision lenses (difference 0.64 D, 95% CI 0.50-0.79), a 71% relative reduction. Axial elongation was 0.21 vs 0.45 mm (difference 0.24 mm, 0.19-0.29), a 53% reduction. Best-corrected acuity was equivalent, and ocular adverse events were similar (11.7% vs 14.6%), none serious or lens-related.
HAL lenses had strong evidence in Chinese children, but it was uncertain whether that carried over to other populations. This trial confirms the effect in US children and underpinned FDA authorisation of the device.
Spectacles are the easiest myopia control to start in a child already wearing glasses: no drops, no contact lenses. Cost will be the main barrier in Indian practice.
- Offer myopia control, not only correction, to progressing myopic children aged 6-12.
- Consider HAL spectacle lenses as a first option where available and affordable.
- Measure axial length at baseline and every 6-12 months where possible.
- Combine with advice on outdoor time and near-work breaks.
- Low-dose atropine remains an alternative or add-on where lenses are not accessible.
Why it matters
A spectacle lens that more than halves axial elongation makes myopia control as simple as the next pair of glasses.
The statistics, in plain English
A 0.64 D difference over two years is clinically meaningful; if sustained, it could keep a child out of high myopia. Axial length is the more reliable measure because it does not depend on refraction technique, and the 53% reduction is consistent with the refraction result.
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