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Purpose <p>To investigate the 1-year preventive efficacy of dual-surface aberration-increasing (DSAI) lenses on axial elongation and refractive change in non-myopic children.</p> Methods <p>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&#xa0;years with cycloplegic spherical equivalent refraction between&#xa0;−0.50 diopters (D) and + 2.00&#xa0;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.</p> Results <p>Enrolment commenced in June 2023. One hundred participants were recruited, and 92 (DSAI group: n = 46, mean ± standard deviation age: 8.15 ± 1.49&#xa0;years; SV group: n = 46, 8.32 ± 1.62&#xa0;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&#xa0;mm; 95% confidence interval [CI]: 0.06 to 0.24&#xa0;mm; <i>P</i> = 0.002) and refractive change (difference:&#xa0;−0.26 D; 95% CI: −0.50 to&#xa0;−0.02 D; <i>P</i> = 0.032) than those in the SV group. Subgroup analysis showed that emmetropic children, older children (8.1–12.0&#xa0;years), and those wearing lenses for longer durations (≥ 11&#xa0;h/day) in the DSAI group had significantly less model-adjusted axial elongation than the corresponding SV subgroups (all <i>P</i> &lt; 0.05).</p> Conclusion <p>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.</p> Trial Registration <p>This trial is registered at Chinese Clinical Trial Registry with trial registration number: ChiCTR2300078464.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月27日

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  • Weiwei Lu,
  • Shiqi Zhou,
  • Lihua Yu,
  • Renai Chen,
  • Ruru Chen,
  • Yang Zhao,
  • Lan Wang,
  • Yi Chen,
  • Fan Lu,
  • Jiawei Zhou,
  • Wanqing Jin

摘要

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.