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

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 < 0.001). The treatment was well tolerated, and no serious adverse events were observed.

Conclusions: Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation in myopic schoolchildren.