Study to Test a New Type of Spectacle Lens for Controlling Myopia in Children Ages 6 to 8

What this Trial Is About

Researchers are evaluating a novel spectacle lens to control myopia progression in young children aged 6 to 8 years. This randomized, controlled, double-masked study aims to validate results from previous trials by comparing the new spectacle lens with a standard single vision, impact-resistant lens. The 12-month results will help predict the treatments effectiveness over three years. Participants are randomly assigned to one of two groups one group will wear the new experimental spectacle lenses, and the other will wear standard single vision lenses. Both types of lenses are impact-resistant. The study requires children to wear their assigned spectacles for at least 10 hours daily, except during sleep, swimming, or other activities where wearing glasses is unsafe or impractical. Children will be involved in the study for 24 months, during which their vision will be regularly checked through tests including spherical equivalent refraction, axial length measurement, and visual acuity assessments. The study monitors how well the lenses control myopia progression and ensures safety by tracking any ocular or systemic conditions. Parent or guardian consent is required for participation.

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens