A 3-arm, 1:1:1 randomized double-masked trial in 225 children aged 6–14 years (myopia −0.50 D to −6.00 D) compared dual-sided composite defocus (DSCD) spectacles vs. single-surface defocus (SSD) and single-vision spectacles (SVS) over 12 months.
DSCD lenses reduced SER progression by 73.6% (−0.22 D vs −0.83 D; P<0.001) and axial elongation by 55.2% (0.19 mm vs 0.42 mm; P<0.001) vs SVS; DSCD also showed significantly less SER progression than SSD (−0.22 D vs −0.45 D; P=0.005), but the axial elongation difference between DSCD and SSD was not statistically significant. No lens-related adverse events occurred.
Follow-up was only 12 months, leaving long-term efficacy and safety unknown. The 13.8% dropout rate may introduce attrition bias. Subgroup findings (age 8–12, AL 24–25 mm, low myopia) were exploratory and hypothesis-generating only.
DSCD spectacles offer a well-tolerated, spectacle-based option that meaningfully slows both refractive progression and axial elongation in children with myopia, particularly those aged 8–12 with low myopia. Clinicians should note the SSD lens used in this trial also outperformed single-vision lenses, so lens design choice matters.
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