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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04967287
Other study ID # MyopiaX-1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 16, 2021
Est. completion date November 30, 2024

Study information

Verified date September 2023
Source Dopavision GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 124
Est. completion date November 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
MyopiaX
MyopiaX treatment twice a day
Myopia control spectacles
To be used all as prescribed

Locations

Country Name City State
Germany Suedblick GmbH Augsburg
Germany MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe Düsseldorf
Germany BeyondEye Clinic Köln
Germany University Medical Center, Johannes Gutenberg- University Mainz
Germany University Eye Hospital Tübingen Tübingen
Netherlands Erasmus University Medical Center Rotterdam
Portugal University of Minho Braga
Spain Hospital Sant Joan de Déu Barcelona
Spain University Complutense of Madrid Madrid
United Kingdom Moorfields Eye Hospital NHS Fundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Dopavision GmbH

Countries where clinical trial is conducted

Germany,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in axial length and in spherical equivalent refractive error Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12 12 months
Other Retinal and choroidal imaging parameters Retinal and choriodal parameters during the course of the trial 12 months
Other Device usability as measured with the user feedback questionnaire Device usability as measured with the user feedback questionnaire at the end of the study 12 months
Primary 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
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