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

Myopia Clinical Trial

— MyopiaX-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04967287
• Other study ID #: MyopiaX-1
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Myopia

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