MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial.

ABSTRACT:

Introduction

Myopia is the most common refractive error worldwide, but each dioptre increase in myopia leads to an increased risk of degenerative eye disease and permanent vision impairment. Soft contact lens (CL) designs have been developed to slow myopia and potentially reduce long-term risk, but there is still a need for additional designs of varied materials and parameters to cater for diverse patient needs. The MultifocAL COntact Lenses for Myopia control study aims to compare the efficacy of the Acuvue Oasys for Presbyopia (AOP) CL against the Food and Drug Administration approved MiSight 1-Day multifocal CL in controlling progressive myopia in children using a non-inferiority contralateral eye design.

Methods and analysis

A double-blind, contralateral eye, non-inferio

SUBMITTER: Dang R 

PROVIDER: S-EPMC11997838 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature