RecruitingNot ApplicableNCT07387159

Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children

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

Sponsor

Hoya Lens Rus LLC

Enrollment

70 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Myopia, Child Myopia Progression

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.

Eligibility

Min Age: 8 YearsMax Age: 11 Years

Inclusion Criteria4

Age 8-11 years (inclusive)
Myopia: spherical equivalent -0.5 to -6.0 D under cycloplegia
No previous myopia control treatment
Orthophoria, presence of binocular vision

Exclusion Criteria4

Corrected visual acuity \< 0.8 (decimal)
Anisometropia \> 2.0 D
Strabismus history or presence
Previous refractive or intraocular surgery

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Interventions

DEVICEMiYOSMART 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

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NCT07387159