Effect of MiYOSMART iQ Spectacle Lenses on Myopia Progression in Children

Introduction and Scientific Rationale Progressive myopia in children is a global public health problem associated with an increased risk of ocular pathology in adulthood. Existing myopia control methods demonstrate efficacy, but there is a need for additional non-pharmacological, non-invasive approaches with a high safety profile and patient acceptability.

MiYOSMART iQ spectacle lenses with DIMS and Triple Enhanced Design (TED) technology represent a modern method of optical myopia control, based on the concept of peripheral myopic defocus.

The efficacy of MiYOSMART lenses has been proven in a number of studies, primarily in Asian populations. However, some physiological aspects of their effect, especially in Caucasian populations and in real-world clinical practice, require further study:

Insufficient data on the precise pattern of induced peripheral defocus when using open-field instruments.

Lack of studies on the effect of defocus segments on contrast sensitivity.

Need for evaluation of key parameter dynamics (refraction, AL) in Russian children.

Scientific Hypothesis: Wearing MiYOSMART iQ spectacles for 6 months leads to a statistically significant slowing of myopia progression (by SE and AL) compared to historical control and causes characteristic, measurable changes in peripheral refraction and contrast sensitivity parameters, detectable at first prescription.

Study Objectives and Endpoints

\- Primary Objective To evaluate the effect of MiYOSMART iQ spectacle lenses on myopia progression after 6 months of wear compared to a historical control group.

Primary Endpoints:

Change in Spherical Equivalent of refraction (SE, D) under cycloplegia (Visit 3 - Visit 1).

Change in Axial Length (AL, mm) (Visit 3 - Visit 1).

\- Secondary Objectives

To characterize the state of the visual system at the first prescription of MiYOSMART iQ lens correction.

Endpoint 1: Peripheral refraction (D) indicators at various retinal points, measured with an open-field autorefractometer without correction and with new spectacles at Visit 2.

Endpoint 2: Spatial contrast sensitivity (log units) indicators for various spatial frequencies, measured with the "Mesotest" device in a trial frame and with new spectacles at Visit 2.

To assess the tolerability and safety of MiYOSMART iQ lens correction over 6 months.

Endpoint: Frequency, nature, and severity of all recorded Adverse Events (AEs) and Device Deficiencies (DDs).

Study Design and Methodology

* Overall Design. Prospective, interventional, single-center study with a historical control group. Responsibility for conduct and scientific supervision rests with the Principal Investigator - Elena P. Tarutta. * Visits and Procedures. The overall schedule is presented below.

Visit 1 (Day 0, Baseline): Informed Consent, Medical History; Visual Acuity (uncorrected, with habitual and optimal correction); Autorefractometry (narrow/wide pupil); Biometry (Axial Length); Binocular Vision, Phoria, AC/A Ratio; Choroidal Thickness Measurement; Recording of Adverse Events/Device Deficiencies.

Visit 2 (within 3±1 weeks after V1): Visual Acuity with new MiYOSMART iQ spectacles; Contrast Sensitivity (Mesotest) in trial frame and new spectacles; Peripheral Refraction without correction and with new spectacles; Dispensing of MiYOSMART iQ spectacles; Recording of Adverse Events/Device Deficiencies.

Visit 3 (Month 6±1 after V1): Visual Acuity with MiYOSMART iQ spectacles; Autorefractometry; Biometry (Axial Length); Binocular Vision, Phoria, AC/A Ratio; Choroidal Thickness Measurement; Recording of Adverse Events/Device Deficiencies.

\- Historical Control Group. Formed retrospectively from the research center's database. Includes patients who met the current study criteria and used single-vision spectacle correction for at least 6 months. Groups will be matched by age (±1 year) and baseline SE (±0.5 D).

• Peripheral Refraction [Time frame: At first prescription (Visit 2, within 3±1 weeks after baseline)]
• Contrast Sensitivity [Time frame: At first prescription (Visit 2, within 3±1 weeks after baseline)]
• Safety - Incidence of Adverse Events [Time frame: Throughout the study period, up to 6 months]