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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 11
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Helmholtz National Medical Research Center of Eye Diseases
RECRUITING
Moscow
Contact Information
Primary
Elena Tarutta, MD, PhD
Otdel_ref_bin2@igb.ru
+7(916)121-19-53
Backup
Nikolai Makukha
makuha@hoya.com
+7(968)88-55-942
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 70
Treatments
Experimental: MiYOSMART iQ intervention group
DIMS with Triple Enhanced Design technology
No_intervention: Historical control group
Retrospective data from patients with single-vision spectacle correction
Related Therapeutic Areas
Sponsors
Leads: Hoya Lens Rus LLC
Collaborators: Helmholtz National Medical Research Center of Eye Diseases

This content was sourced from clinicaltrials.gov