Clinical study on the effect of multifocal contact lenses on myopia progression in myopia school children

Miho Kojima,Tetsuro Oshika,Chie Sotozono,Osamu Hieda,Takahiro Hiraoka,Yo Nakamura

doi:10.1186/s13063-021-05197-6

Miho Kojima, Tetsuro Oshika

Open Access

https://doi.org/10.1186/s13063-021-05197-6

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Abstract

BackgroundThe efficacy of peripheral low add multifocal soft contact lenses (SCLs) for suppressing the progression of myopia is controversial. The aim of the on-going present clinical study is to investigate whether or not multifocal SCLs with + 0.50 diopters (D) addition suppress the progression of myopia in myopic elementary school children.DesignProspective randomized controlled trial.Subjects and methodsThe study plans to include a total of 100 myopic school children. Target subjects are primary school male and female students with mild to moderate myopia. Children who have eye-related diseases other than myopia are excluded from the study, because they may affect the evaluation of the outcome. Subjects will be randomly assigned to wear daily disposable multifocal contact lenses with + 0.50D addition or daily disposable SCLs. Subjects will wear contact lenses on both eyes and will be observed for 2 years under a double-masked examination. Primary outcome is a change in the axial length over the 2-year period.ObjectivesThe purpose of this study is to identify whether or not multifocal SCLs with + 0.5D addition suppress the progression of myopia in myopic elementary school children as compared with standard SCLs.Trial registration1. UMIN (University Hospital Medical Information Network) UMIN000027940. Registered on July 21, 20172. JRCT (Japan Registry of Clinical Trials) jRCTs052180172. Registered on March 26, 2019

Highlights

High incidence of myopia in children is a growing problem in Japan
The purpose of this study is to identify whether or not multifocal Soft contact lens (SCL) with + 0.5D addition suppress the progression of myopia in myopic elementary school children as compared with standard SCLs
Previous studies show that three types of SCL are effective for suppressing the progression of myopia, namely, concentric bifocal lenses [13], extended depth of focus lenses [14], and peripheral add multifocal SCL

Summary

Introduction

High incidence of myopia in children is a growing problem in Japan. Myopia has been more frequently found in lowergrade elementary school children. When myopia develops at a younger age, it tends to progress, suggesting an increased incidence rate of high myopia in the future [2]. The increased risk of developing complications such as high myopia-associated retinal detachment, glaucoma, myopic macular degeneration, myopic optic neuropathy, or cataracts is of growing concern. The efficacy of peripheral low add multifocal soft contact lenses (SCLs) for suppressing the progression of myopia is controversial. The aim of the on-going present clinical study is to investigate whether or not multifocal SCLs with + 0.50 diopters (D) addition suppress the progression of myopia in myopic elementary school children

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Conclusion