Refractive and biometric outcomes with aspheric vs. EDOF contact lenses in pediatric myopia control: a 12-month randomized trial

Abstract

Introduction/Objectives: Myopia, a refractive error linked to childhood axial elongation, causes blurred distance vision. As prevalence rises globally, interventions are needed to control progression while preserving the emmetropization. This study evaluated the impact of three soft contact lens designs (two aspheric multifocal, one extended depth-of-focus [EDOF]) on refractive and biometric parameters, and their effectiveness in controlling myopia progression over 12 months. Materials and Methods: A double-blind randomized trial involved 36 children aged 7-13 years, equally allocated into three groups: two using different aspheric multifocal lenses (Groups I and II) and one using an EDOF design (Group III). Evaluations were at baseline (M0), 6 months (M6), and 12 months (M12). Spherical Equivalent Refraction (SER), corneal curvature (K1 and K2), axial length (AL) and white-to-white (WTW) distance were measured with an open-field autorefractometer (NVISION-K 5001) and an optical biometer (Topcon MYAH). Results: All lens designs showed significant myopia progression over 12 months based on SER and AL (ANOVA or Friedman: both p<0.001), but changes stayed below literature thresholds (one-sample t-test, all p≤0.028). K1 was stable in Groups I and II (ANOVA, both p≥0.147), but flattened significantly in Group III between M0 vs. M6 and M12 (Bonferroni, p≤0.017). K2 was stable in Groups I and III (ANOVA, both p≥0.077), but steepened in Group II from M0 to M12 (Bonferroni, p≤0.002). WTW increased significantly in all groups (Bonferroni, all p≤0.036). Conclusions: Despite longitudinal changes in refractive and biometric parameters, all three lens designs effectively slowed myopia progression over 12 months compared to literature thresholds.