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

Dopavision GmbH124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

124

Conditions

Myopia

Interventions

MyopiaXDEVICE

MyopiaX treatment twice a day

Myopia control spectaclesDEVICE

To be used all as prescribed

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (10)

Suedblick GmbH

Augsburg, Germany

BeyondEye Clinic

Cologne, Germany

MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe

Düsseldorf, Germany

University Medical Center, Johannes Gutenberg- University

Mainz, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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