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Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children

NCT07387159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Myopia, Child Myopia Progression

Interventions

DEVICE

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

Sponsors & Collaborators

  • Helmholtz National Medical Research Center of Eye Diseases

    collaborator UNKNOWN

  • Hoya Lens Rus LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07387159 on ClinicalTrials.gov