Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia Progression Among Taiwanese Schoolchildren: A Randomized Paired-Eye Clinical Trial

Abstract Introduction To evaluate the efficacy and safety of myopia control using a multifocal soft contact lens designed with high peripheral add power in schoolchildren. Methods This 1-year multi-center, prospective, randomized, double-blind, controlled study enrolled myopic schoolchildren aged 6–15 years with refractive errors between − 1.0 D and − 10.0 D. Each participant was randomly allocated to wear a daily disposable multifocal soft contact lens as the treatment in one eye and a single-vision soft contact lens as the control in the other eye. The primary endpoints were changes in the cycloplegic spherical equivalent (SE) and axial length at 1 year. Results Fifty-two of the 59 participants (88.1%) completed the study protocol. The mean change in SE was − 0.73 ± 0.40 D in the treatment group. and − 0.85 ± 0.51 D in the control group (mean difference: − 0.12 ± 0.34 D, p = 0.012). The mean change in axial length was 0.25 ± 0.14 mm in the treatment group, and 0.33 ± 0.17 mm in the control group (mean difference: 0.08 ± 0.10 mm, p