Aberration-Enhanced Dual-Surface Lens Versus Single-Vision Lens in Non- Myopic Children A Randomized Clinical Trial

Purpose To investigate the 1-year efficacy of an aberration-enhanced dual-surface (AEDS) lens in slowing axial elongation and refraction changes in non-myopic children. Methods A 2-year randomized controlled, prospective trial with a planned interim analysis after the 1-year follow-up to assess the preliminary efficacy and safety of the AEDS lens. One hundred children aged 6–12 years with cycloplegic spherical equivalent refraction (SER) between − 0.50 diopter (D) and + 3.00 D were recruited. Participants were randomly assigned to wear AEDS spectacle lenses or single-vision (SV) spectacle lenses in their daily lives. The main outcomes were the change in axial length and cycloplegic SER from baseline. Results One hundred participants were enrolled from July to October 2023. Ninety-two participants (AEDS 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. Participants in the AEDS group exhibited significantly less axial elongation (difference, 0.15mm; P  = 0.002) and cycloplegic SER change (difference, -0.26 D; P  = 0.01) compared with the SV group. Subgroup analysis revealed that emmetropic children, older children (8.1–12.0 years), and those wearing lenses for longer durations (≥ 11 hours/day) in the AEDS group showed significantly less model-adjusted axial elongation than did the corresponding SV subgroups (all P  < 0.05). Conclusion The AEDS lens effectively slows axial elongation and refraction changes, especially in emmetropic children, older children and those who wore the lenses for longer durations, indicating its potential benefits for children seeking myopia prevention. Trial Registration ChiCTR.org.cn Identifier: ChiCTR2300078464