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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Myopia control spectacles; Device: MyopiaX

• Registration Number: NCT04967287
• Lead Sponsor: Dopavision GmbH

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-19
• Study Start: 2021-11-16
• Status Verified: 2024-10
• Primary Completion: 2024-10-04
• Study Completion: 2024-10-04
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myopia control spectacles	Myopia control spectacles	Clinically validated treatment to control myopia
MyopiaX	MyopiaX	MyopiaX treatment

Primary Outcome Measures

Name	Time	Method
Change in axial length and in spherical equivalent refractive error	6 months	Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.

Trial Locations

Locations (10)

MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe; 🇩🇪 Düsseldorf, Germany

Suedblick GmbH; 🇩🇪 Augsburg, Germany

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center, Johannes Gutenberg- University; 🇩🇪 Mainz, Germany

University Eye Hospital Tübingen; 🇩🇪 Tübingen, Germany

Hospital Sant Joan de Déu; 🇪🇸 Barcelona, Spain

University Complutense of Madrid; 🇪🇸 Madrid, Spain

Moorfields Eye Hospital NHS Fundation Trust; 🇬🇧 London, United Kingdom

University of Minho; 🇵🇹 Braga, Portugal

BeyondEye Clinic; 🇩🇪 Köln, Germany