Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children

NCT07387159 | Recruiting

• 1 other identifier: MIYOSMART-iQ-OFT-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myopia control, spectacle lenses, peripheral defocus, DIMS, MiYOSMART

Outcome Measures

Primary Outcomes (2)

• Change in Axial Length

  Change in axial length, measured in millimeters (mm)

  Baseline to 6 months

• Change in Spherical Equivalent Refraction

  Change in cycloplegic spherical equivalent refraction, measured in diopters (D)

  Baseline to 6 months

Secondary Outcomes (3)

• Peripheral Refraction

  At first prescription (Visit 2, within 3±1 weeks after baseline)

• Contrast Sensitivity

  At first prescription (Visit 2, within 3±1 weeks after baseline)

• Safety - Incidence of Adverse Events

  Throughout the study period, up to 6 months

Study Arms (2)

MiYOSMART iQ intervention group

EXPERIMENTAL

DIMS with Triple Enhanced Design technology

Device: MiYOSMART iQ spectacle lenses

Historical control group

NO INTERVENTION

Retrospective data from patients with single-vision spectacle correction

Interventions

MiYOSMART iQ spectacle lenses DEVICE

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

MiYOSMART iQ intervention group

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoya Lens Rus LLC: lead
• Helmholtz National Medical Research Center of Eye Diseases: collaborator

Study Sites (1)

Helmholtz National Medical Research Center of Eye Diseases

Moscow, 105062, Russia

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Elena Tarutta, MD, PhD

CONTACT

+7(916)121-19-53; Otdel_ref_bin2@igb.ru

Nikolai Makukha

CONTACT

+7(968)88-55-942; makuha@hoya.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)