Actively Recruiting
Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children
Led by Hoya Lens Rus LLC · Updated on 2026-02-06
70
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
H
Hoya Lens Rus LLC
Lead Sponsor
H
Helmholtz National Medical Research Center of Eye Diseases
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 to 11 years inclusive
- Myopia with spherical equivalent between -0.5 and -6.0 diopters under cycloplegia
- No previous myopia control treatment
- Orthophoria (normal eye alignment) and presence of binocular vision
You will not qualify if you...
- Corrected visual acuity less than 0.8 (decimal)
- Anisometropia greater than 2.0 diopters
- History or presence of strabismus
- Previous refractive or intraocular surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Helmholtz National Medical Research Center of Eye Diseases
Moscow, Russia, 105062
Actively Recruiting
Research Team
E
Elena Tarutta, MD, PhD
CONTACT
N
Nikolai Makukha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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