Clinical Trial

Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children

Recruiting
View on ClinicalTrials.gov →
Summary
This prospective, single-center study aims to evaluate the efficacy and safety of MiYOSMART iQ spectacle lenses with DIMS (Defocus Incorporated Multiple Segments) and Triple Enhanced Design (TED) technology in slowing myopia progression in children aged 8-11 years. 35 children with myopia (spherical equivalent -0.5 to -6.0 D) will be prescribed MiYOSMART iQ lenses and followed for 6 months. The study will compare changes in spherical equivalent refraction and axial length against a historical control group (n=35) using ANCOVA. Secondary outcomes include measurements of peripheral refraction and contrast sensitivity at the first prescription. The study hypothesis is that wearing MiYOSMART iQ lenses for 6 months significantly slows myopia progression compared to single-vision spectacle correction.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-28.
Status change: Not Yet Recruiting → Recruiting 2026-02-05
Trial Details
NCT Number NCT07387159
Lead Sponsor Hoya Lens Rus LLC
Collaborators: Helmholtz National Medical Research Center of Eye Diseases
Conditions Myopia, Child Myopia Progression
Enrollment 70 participants
Start Date 2026-02-04
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-02-06