Randomized six-month trial of aspheric vs. EDOF contact lenses for pediatric myopia control

Abstract

Introduction: Myopia, characterized by excessive refractive power, causes images of distant objects to form in front of the retina, resulting in blurred vision. Increased axial length of the eyeball is a common biometric feature of myopia. Given the rising prevalence of myopia and its associated risks, effective interventions to control its progression, especially in children, are crucial. Purpose: This study aimed to compare the efficacy of two different optical designs in contact lenses in controlling myopia progression or ocular elongation in a paediatric population over a short period. METHODS: A randomized, double-blind, prospective clinical trial was conducted over two years, with interim results analysed after six months. The study involved myopic children aged 7-13 years. Participants were assigned to either an aspheric optical design multifocal lens group or an extended depth of focus (EDOF) optical design contact lens group. Participants were scheduled for three sessions three months apart: baseline (M0), 3-month session (M3), and 6-month session (M6). In all sessions, spherical equivalent refraction (SER) was measured using the NVISIONK 5001 open-field autorefractometer, while axial length (AL) was assessed with the Topcon MYAH optical biometer. Results: Initial comparisons showed no significant differences between the groups in age, visual acuity, SER, or AL (all p = 0.738). Over six months, significant SER changes were found in both, aspheric lenses (ANOVA, p = 0.022) and EDOF lenses (ANOVA, p < 0.001). Additionally, the aspheric multifocal group showed significant AL elongation only when comparing the M0 to the M6 follow-up (Wilcoxon test, p = 0.009), whereas the EDOF group showed significant AL changes across all sessions (Wilcoxon test, Wilcoxon test, all p ≤ 0.021). CONCLUSION: The findings suggest that neither aspheric multifocal lenses nor EDOF lenses are fully effective in slowing myopia progression in children over short periods. However, aspheric lenses show a greater tendency to control AL than EDOF multifocal lenses, despite both groups exhibiting significant changes over time.