Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children
ConditionMyopia, Child Myopia Progression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-11
SponsorHoya Lens Rus LLC
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Corrected visual acuity < 0.8 (decimal)
Anisometropia > 2.0 D
Strabismus history or presence
Previous refractive or intraocular surgery
Trial design
Treatments tested in this trial
- MiYOSMART iQ spectacle lenses
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hoya Lens Rus LLC
Lead sponsor
Helmholtz National Medical Research Center of Eye Diseases
Collaborator
Source ClinicalTrials.gov