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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04967287
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 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 : December 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 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 BCVA 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

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


Contacts
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Contact: Ida Zuendorf, PhD +49 17620904189 zuendorf@dopavision.com
Contact: Clinical Trials clinicaltrials@dopavision.com

Locations
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Germany
MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe Recruiting
Düsseldorf, Germany, 40549
Contact: Hakan Kaymak, Dr.         
BeyondEye Clinic Not yet recruiting
Köln, Germany
Contact: Roxana Fulga, Dr.         
University Medical Center, Johannes Gutenberg- University Not yet recruiting
Mainz, Germany
Contact: Katrin Lorenz, PD Dr.         
University Eye Hospital Tübingen Recruiting
Tübingen, Germany
Contact: Tobias Peters, Dr.         
Netherlands
Erasmus University Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Caroline Klaver, Prof.         
Portugal
University of Minho Recruiting
Braga, Portugal
Contact: José Gonzlez Méijome, Prof.         
Spain
University Complutense of Madrid Recruiting
Madrid, Spain
Contact: Gonzalo Carracedo, Prof.         
United Kingdom
Moorfields Eye Hospital NHS Fundation Trust Not yet recruiting
London, United Kingdom
Contact: Annegret Dahlmann-Nohr, Dr.         
Sponsors and Collaborators
Dopavision GmbH
Investigators
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Study Chair: Ian Flitcroft, Prof. Centre for Eye Reserach Ireland, Technological University Dublin
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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: January 23, 2023
Last Verified: January 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