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Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children
Sponsor: Hoya Lens Rus LLC
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.
Official title: Prospective, Interventional, Single-center Study to Evaluate the Influence of MiYOSMART iQ Spectacle Lenses With DIMS and Triple Enhanced Design Technology on Refraction Dynamics, Biometric Parameters, Peripheral Refraction and Contrast Sensitivity in Children With Myopia
Key Details
Gender
All
Age Range
8 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-02-04
Completion Date
2027-02-28
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
MiYOSMART iQ spectacle lenses
MiYOSMART iQ are single-vision spectacle lenses made of polycarbonate (refractive index 1.59) featuring Defocus Incorporated Multiple Segments (DIMS) technology with Triple Enhanced Design (TED). The lens contains a central optical zone for clear distance vision, surrounded by multiple, uniformly distributed micro-lens segments (diameter: \~1.00 mm) that create a consistent myopic defocus signal of +4.50 D across the peripheral retina. This specific optical design aims to slow axial elongation in progressing myopia. The intervention involves full-time wear of spectacles with these lenses. The device is CE-marked and has Russian registration certificate No. ФСЗ 2012/11555 dated December 5, 2024
Locations (1)
Helmholtz National Medical Research Center of Eye Diseases
Moscow, Russia