Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: MiYOSMART iQ intervention groupExperimental treatment 1 intervention
Group B: Historical control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Axial Length

Change in axial length, measured in millimeters (mm)

Time frame
Baseline to 6 months
2

Change in Spherical Equivalent Refraction

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

Time frame
Baseline to 6 months

Secondary outcomes

1

Peripheral Refraction

Peripheral refraction values at various retinal points (e.g., 20° and 30° nasally, temporally, superiorly, inferiorly), measured in diopters (D) with an open-field autorefractometer, without correction and with new MiYOSMART iQ spectacles

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

Contrast Sensitivity

Spatial contrast sensitivity (log units) for various spatial frequencies, measured with the "Mesotest" device in a trial frame and with new MiYOSMART iQ spectacles

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

Safety - Incidence of Adverse Events

Frequency, nature, and severity of all recorded Adverse Events (AEs) and Device Deficiencies (DDs) related to the use of MiYOSMART iQ spectacles.

Time frame
Throughout the study period, up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoya Lens Rus LLC

Lead sponsor

Helmholtz National Medical Research Center of Eye Diseases

Collaborator

Source ClinicalTrials.gov
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