MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation (MyopiaX-1)

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: MyopiaX; Device: Myopia control spectacles

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 Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Suedblick GmbH
  • Düsseldorf, Germany, 40549
    • MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
  • Köln, Germany
    • BeyondEye Clinic
  • Mainz, Germany
    • University Medical Center, Johannes Gutenberg- University
  • Tübingen, Germany
    • University Eye Hospital Tübingen
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus University Medical Center
• Portugal
  • Braga, Portugal
    • University of Minho
• Spain
  • Barcelona, Spain
    • Hospital Sant Joan de Déu
  • Madrid, Spain
    • University Complutense of Madrid
• United Kingdom
  • London, United Kingdom
    • Moorfields Eye Hospital NHS Fundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in axial length	Change in axial length (mm) from baseline to 24 months as measured by optical biometry	24 months
Change in spherical equivalent refraction	Change in spherical equivalent refraction (D) from baseline to 12 months as measured by cycloplegic autorefraction	12 months
Changes in axial length	Changes in axial length (mm) from baseline to 6, 12, and18 months as measured by optical biometry	6, 12, and 18 months
Parent reported outcome - satisfaction with MyopiaX	Questionnaire created to evaluate parents satisfaction with the device and treatment concept	12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Retinal and choroidal imaging parameters	Retinal and choriodal parameters during the course of the trial	12 months
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

Collaborators and Investigators

• Sponsor: Dopavision GmbH
• Investigators: Study Chair: Ian Flitcroft, Prof., Centre for Eye Reserach Ireland, Technological University Dublin

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): October 4, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Digital treatment
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: MyopiaX-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No