MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.

Detailed Description
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The present study is a multicentric, randomized, controlled, single masked trial to investigate the signals of effect, the safety and tolerability of MyopiaX in slowing the progression of myopia. The trial consists of 12 months treatment period. The first 6 months participants will be treated either with MyopiaX or with myopia control spectacles. During the second half of the trial, participants treated with MyopiaX will receive the myopia control spectacles in addition. 81 children and adolescent aged 6 - 12 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 ratio to either the MyopiaX or the myopia control spectacles group.

Official Title
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MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation

Conditions
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Myopia

Intervention / Treatment
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* Device: MyopiaX
* Device: Myopia control spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myopic children (-0.75 to -5.0 D SER, least myopic meridian -0.50 D in each eye) At least VA 0.2 LogMAR in each eye Age: 6 - 12 years old Good tolerability of test session with VR system Binocular adequacy as tested with VR Ability to understand treatment and give valid assent Exclusion Criteria: Concomitant or previous therapies for myopia Eye diseases/conditions: Anisometropia ≥ 1.5 D Astigmatism ≥ 3 D Ophthalmological comorbidities Optic nerve abnormalities Suspicion of syndromic or monogenetic myopia Systemic illnesses affecting eye health, eye growth, and/or refraction Any illnesses affecting dopamine function (e.g., sleep disorder) Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (such as allergy medications) Participation in other clinical studies Medical history (or family history) of photosensitive epilepsy

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyopiaX<br>MyopiaX treatment | Device: MyopiaX<br>* MyopiaX treatment twice a day<br>|
| Active Comparator: Myopia control spectacles<br>Clinically validated treatment to control myopia | Device: Myopia control spectacles<br>* To be used all as prescribed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in axial length and in spherical equivalent refractive error | Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital treatment