Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children

Brief Summary

Background: Myopia (nearsightedness) is a growing global health concern, projected to affect 50% of the world population by 2050. Children with progressive myopia are at risk of serious ocular complications including myopic maculopathy, glaucoma, and retinal detachment. Low-dose atropine (0.05%) has shown efficacy in slowing myopia progression, and optical interventions such as bifocal spectacles may provide additional benefits by altering peripheral retinal defocus. Objective: This randomized controlled trial aims to compare the efficacy and effectiveness of atropine 0.05% monotherapy versus combination therapy (atropine 0.05% plus bifocal spectacles) in controlling myopia progression in children. Methods: Children aged 4-16 years with bilateral myopia (cycloplegic spherical equivalent between -1.00 D and -6.00 D) and documented recent progression (≥ -0.50 D in the preceding 12 months) will be randomized 1:1 to receive either atropine 0.05% eye drops once daily or atropine 0.05% plus bifocal spectacles. The primary outcome is change in spherical equivalent refraction over 12 months; the secondary outcome is change in axial length. Follow-up visits occur at 3, 6, 9, and 12 months. Conclusion: This study will provide evidence on whether adding bifocal correction to pharmacological therapy offers superior myopia control compared to atropine alone, informing clinical practice guidelines for pediatric myopia management.