Effect of Variation in Extended Depth-Of-Focus Design on Myopia Control and Visual Function in Japanese Children

OBJECTIVES: To evaluate the efficacy of extended depth-of-focus (EDOF) soft contact lenses with different optical profiles in controlling myopia progression and their effect on visual function in Japanese children. METHODS: In this 12-month multicenter, double-masked, randomized controlled trial, 60 Japanese children aged 6 to 12 years were assigned to wear two types of EDOF soft contact lenses with different depths of focus (Mid-EDOF [+1.50 D] or Low-EDOF [+0.75 D]) or single-vision daily disposable contact lenses (control). Axial length and cycloplegic spherical equivalent (SE) were measured at 6 and 12 months. Visual function, including contrast sensitivity, higher-order aberrations (HOAs), and subjective visual quality, was assessed at baseline and follow-up. RESULTS: Mid-EDOF lenses significantly suppressed axial elongation and SE progression by 49% and 59%, respectively, compared with single-vision lenses (P<0.01). Low-EDOF lenses exerted no significant effect on axial elongation or SE progression. Visual function assessments revealed reduced contrast sensitivity and increased HOAs in the Mid-EDOF group; subjective visual quality remained comparable across groups. No serious adverse events were reported. CONCLUSION: Mid-EDOF lenses significantly suppress myopia progression, with tolerable visual function changes, potentially providing effective myopia control. Low-EDOF lenses showed no significant benefit over single-vision lenses. EDOF lenses' optical profile critically affects treatment efficacy.