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

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.

Timeline

Start

2025-02-17

Primary completion

2026-04-30

Completion

2026-05-15

Drugs

Indications