Clinical study on the effect of multifocal contact lenses on myopia progression in myopia school children: Multifocal contact lens study for suppression of myopia progression

BACKGROUND: 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. DESIGN: Prospective randomized controlled trial. SUBJECTS AND METHODS: The 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. OBJECTIVES: The 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 REGISTRATION: 1. UMIN (University Hospital Medical Information Network) UMIN000027940. Registered on July 21, 2017 2. JRCT (Japan Registry of Clinical Trials) jRCTs052180172. Registered on March 26, 2019