Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial

Abstract

Introduction

This study aimed to assess the safety and efficacy of a novel extended-depth-of-focus (EDOF) soft contact lens for myopia control in children.

Methods

A prospective, multicenter, randomized, double-masked, placebo-controlled, contralateral-eye comparison clinical trial was conducted in 72 children (40 male and 32 female) aged 9 to 14 years, with each eye randomly selected to wear either an experimental EDOF contact lens or a single-vision control lens at least 8 h per day, 5 days a week, for 52 weeks. Each contact lens was worn and then replaced daily. Measurements including best-corrected visual acuity, spherical equivalent refractive error (SER), axial length (AXL), and keratometry were performed at weeks 1, 4, and 13, and every 13 weeks thereafter for 52 weeks. The primary outcome measure was the change in SER, measured using cycloplegic auto-refraction. The secondary outcome measure was the change in AXL.

Results

At week 52, the mean change in SER was significantly lower with the experimental lens (−0.70 ± 0.49 D) than with the control lens (−0.88 ± 0.51 D; P < .001). The mean AXL elongation was significantly lower with the experimental lens (0.34 ± 0.19 mm) than with the control lens (0.38 ± 0.19 mm; P < .001). The EDOF lens reduced AXL and myopia progression by 10.5% and 20.5%, respectively. The change in SER, but no AXL, was significantly associated with EDOF lens wear in adjusted multivariate regression analysis. Reported adverse events did not differ significantly between the two lens types.

Conclusions

The results of this 1-year clinical trial demonstrate that the experimental EDOF soft contact lens slows myopia progression and reduces AXL elongation in children compared with a single-vision contact lens. (This study was retrospectively registered with ClinicalTrials.gov; identifier: NCT04238897; date of registration: January 23, 2020.)