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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04967287
Recruitment Status : Active, not recruiting
First Posted : July 19, 2021
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Dopavision GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Device: MyopiaX Device: Myopia control spectacles Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in axial length and in spherical equivalent refractive error [ Time Frame: 6 months ]
    Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.


Other Outcome Measures:
  1. Change in axial length and in spherical equivalent refractive error [ Time Frame: 12 months ]
    Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12

  2. Retinal and choroidal imaging parameters [ Time Frame: 12 months ]
    Retinal and choriodal parameters during the course of the trial

  3. Device usability as measured with the user feedback questionnaire [ Time Frame: 12 months ]
    Device usability as measured with the user feedback questionnaire at the end of the study


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04967287


Locations
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Germany
Suedblick GmbH
Augsburg, Germany
MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
Düsseldorf, Germany, 40549
BeyondEye Clinic
Köln, Germany
University Medical Center, Johannes Gutenberg- University
Mainz, Germany
University Eye Hospital Tübingen
Tübingen, Germany
Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Portugal
University of Minho
Braga, Portugal
Spain
Hospital Sant Joan de Déu
Barcelona, Spain
University Complutense of Madrid
Madrid, Spain
United Kingdom
Moorfields Eye Hospital NHS Fundation Trust
London, United Kingdom
Sponsors and Collaborators
Dopavision GmbH
Investigators
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Study Chair: Ian Flitcroft, Prof. Centre for Eye Reserach Ireland, Technological University Dublin
More Information
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Responsible Party: Dopavision GmbH
ClinicalTrials.gov Identifier: NCT04967287    
Other Study ID Numbers: MyopiaX-1
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dopavision GmbH:
Digital treatment
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases