Dual-surface aberration-increasing lenses versus single-vision lenses in non-myopic children: a randomized clinical trial

PURPOSE: To investigate the 1-year preventive efficacy of dual-surface aberration-increasing (DSAI) lenses on axial elongation and refractive change in non-myopic children. METHODS: This was a 2-year randomized, controlled, prospective trial with a planned interim analysis at the 1-year follow-up to assess the preliminary efficacy and safety of DSAI lenses. One hundred children aged 6-12 years with cycloplegic spherical equivalent refraction between -0.50 diopters (D) and + 2.00 D, classified as non-myopic, were recruited. Participants were randomly assigned to wear either DSAI spectacle lenses or single-vision (SV) spectacle lenses in daily life. The primary outcomes were axial elongation and refractive change relative to baseline measurements, with axial elongation considered the main structural outcome in the results. RESULTS: Enrolment commenced in June 2023. One hundred participants were recruited, and 92 (DSAI group: n = 46, mean ± standard deviation age: 8.15 ± 1.49 years; SV group: n = 46, 8.32 ± 1.62 years) completed the 1-year follow-up. No intervention-related adverse events were observed during the study period. Participants in the DSAI group exhibited significantly less axial elongation (difference: 0.15 mm; 95% confidence interval [CI]: 0.06 to 0.24 mm; P = 0.002) and refractive change (difference: -0.26 D; 95% CI: -0.50 to -0.02 D; P = 0.032) than those in the SV group. Subgroup analysis showed that emmetropic children, older children (8.1-12.0 years), and those wearing lenses for longer durations (≥ 11 h/day) in the DSAI group had significantly less model-adjusted axial elongation than the corresponding SV subgroups (all P < 0.05). CONCLUSION: The 1-year interim results suggest that DSAI lenses help to slow axial elongation and refractive change in non-myopic children, with a relatively greater effect observed in emmetropic children, older children, and those who wore the lenses for longer durations. TRIAL REGISTRATION: This trial is registered at Chinese Clinical Trial Registry with trial registration number: ChiCTR2300078464.