drugset / Trial / NCT05062031

Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

NCT05062031

RandomizedParallel-groupOpen-labelTreatment

Summary

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation. Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses. The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

Timeline

Start
2021-10-19
Primary completion
2026-02
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atropine Other / unclassified 0.05 % Other

Indications