- Design
- Double-masked randomised clinical trial, 9 US sites
- Population
- 159 children aged 6–12 with −0.75 to −4.50 D myopia
- Primary outcome
- 24-month change in cycloplegic refraction and axial length
- Effect
- Refraction difference 0.64 D (0.50–0.79); axial length −0.24 mm (−0.29 to −0.19)
Spectacle lenses with rings of highly aspherical lenslets had shown benefit in Asian children. This double-masked randomised trial at nine US sites enrolled 159 children aged 6 to 12 with −0.75 to −4.50 D of myopia and no prior myopia control, assigning them to lenslet or single-vision spectacles.
At 24 months, myopia progressed by −0.25 D with lenslet lenses against −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 mm against 0.45 mm (difference −0.24 mm), a 53% reduction. Best-corrected acuity was equivalent, and adverse events were similar and none lens-related. The results supported FDA authorisation of the device.
With effects now replicated outside Asia, lenslet spectacles sit alongside low-dose atropine and myopia-control contact lenses as evidence-based options. Spectacles avoid the hygiene demands of contact lenses in younger children. Longer follow-up is needed to show the effect persists and to examine rebound after stopping.
- Offer myopia-control spectacles with aspherical lenslets as an option for progressing myopia in children aged 6 to 12.
- Expect slower axial growth: about half that with single-vision lenses over two years.
- Consider spectacles where contact lens hygiene or atropine adherence is a concern.
- Monitor axial length every 6 to 12 months to confirm response.
- Check local availability and cost before recommending; these lenses cost more than single-vision spectacles.
Why it matters
It confirms a non-drug, non-contact-lens option works beyond the populations where it was first tested.
Don't overread it
Two-year data; whether the effect persists or rebounds after stopping is not yet known.
The statistics, in plain English
A difference of 0.64 D over two years is clinically meaningful — more than a year's progression in the untreated group. The 53% reduction in axial growth is the more important figure, because eye length drives later complications.
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