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

Elizabeth P Shen, Hsiao-Sang Chu, Han-Chih Cheng, Tzu-Hsun Tsai, Elizabeth P Shen, Hsiao-Sang Chu, Han-Chih Cheng, Tzu-Hsun Tsai

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.).

Keywords: Axial length; Children; Extended depth of focus; Myopia control; Soft contact lens.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the participants from screening to study completion
Fig. 2
Fig. 2
Design of the experimental EDOF soft contact lens. a Two-dimensional plot depicting the power profile design of the contact lens. The color intensity represents the power amplitude. b During near viewing, light passes through the constricted pupil, and the central under-corrected refractive power decreases the amplitude of the required accommodation. c During distance viewing, light passes through the refractive power profile of the lens across the optic zone, making points at, anterior to, and posterior to the retina, ultimately producing a simultaneous image for distance viewing. EDOF extended depth of focus
Fig. 3
Fig. 3
Changes in spherical equivalent refractive error (SER) and axial length (AXL) in the two groups over the study period. a SER. b AXL. *Statistically significant difference between groups

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