MiYOSMART iQ spectacle lenses to slow myopia 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
This study will test whether MiYOSMART iQ DIMS spectacle lenses slow myopia progression in 8–11-year-old children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 8 Years to 11 Years |
| Sex | All |
| Sponsor | Hoya Lens Rus LLC Industry-sponsored |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07387159 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center study will enroll 35 children aged 8–11 years with cycloplegic spherical equivalent between −0.5 and −6.0 D who will be prescribed MiYOSMART iQ spectacle lenses and followed for six months. Changes in spherical equivalent refraction and axial length will be compared to a historical control group (n=35) using ANCOVA. Secondary outcomes include measurements of peripheral refraction and contrast sensitivity at the first prescription, and safety data will be collected throughout. The trial is designed to characterize DIMS/TED optical effects in a Russian pediatric population and in a real-world clinical setting.
Who should consider this trial
Good fit: Children aged 8–11 years with cycloplegic myopia of −0.5 to −6.0 D, normal binocular vision, and no prior myopia-control treatment are ideal candidates.
Not a fit: Children outside the age or prescription range, or those with poor corrected visual acuity, anisometropia >2.0 D, strabismus, or prior refractive/intraocular surgery are unlikely to benefit.
Why it matters
Potential benefit: If successful, these lenses could slow myopia progression in young children and reduce their long-term risk of sight-threatening eye disease.
How similar studies have performed: Previous trials, mainly in Asian populations, have shown MiYOSMART/DIMS lenses can slow myopia progression, but evidence in Caucasian cohorts and short-term real-world settings is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Corrected visual acuity \< 0.8 (decimal) * Anisometropia \> 2.0 D * Strabismus history or presence * Previous refractive or intraocular surgery
Where this trial is running
Moscow
- Helmholtz National Medical Research Center of Eye Diseases — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Elena Tarutta, MD, PhD
- Email: Otdel_ref_bin2@igb.ru
- Phone: +7(916)121-19-53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.