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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 : November 29, 2021
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 adolescent.

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

Detailed Description:

The present study is a multicentric, randomized controlled, double masked trial to investigate the safety and efficacy of MyopiaX, a digital treatment to slow myopia progression as compared to a sham treatment.

The trial consists of a 24 month active treatment period followed by a 12 month- treatment free follow-up. 234 children and adolescent aged 6 - 14 years will be included in the trial. Eligible subjects will be randomly assigned in a 2:1 distribution to either the treatment or the sham group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, 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 : March 30, 2024
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MyopiaX
MyopiaX treatment
Device: MyopiaX
MyopiaX treatment twice a day

Sham Comparator: Sham
Sham comparator using the same device and components but without the actual treatment
Device: Sham
Sham device usage twice a day




Primary Outcome Measures :
  1. Change in spherical equivalent refraction [ Time Frame: 24 months ]
    Change in spherical equivalent refraction (D) from baseline to 24 months as measured by cycloplegic autorefraction.


Secondary Outcome Measures :
  1. Change in axial length [ Time Frame: 24 months ]
    Change in axial length (mm) from baseline to 24 months as measured by optical biometry

  2. Change in spherical equivalent refraction [ Time Frame: 12 months ]
    Change in spherical equivalent refraction (D) from baseline to 12 months as measured by cycloplegic autorefraction

  3. Changes in axial length [ Time Frame: 6, 12, and 18 months ]
    Changes in axial length (mm) from baseline to 6, 12, and18 months as measured by optical biometry

  4. Parent reported outcome - satisfaction with MyopiaX [ Time Frame: 12 and 24 months ]
    Questionnaire created to evaluate parents satisfaction with the device and treatment concept



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 - 14 years old
  • Evidence of myopia progression over the preceding year (≤ -0.25 D /year at least)
  • 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 Not yet recruiting
Düsseldorf, Germany, 40549
Contact: Hakan Kaymak, Dr.         
University Eye Hospital Tübingen Recruiting
Tübingen, Germany
Contact: Tobias Peters, Dr.         
Ireland
Centre for Eye Research Ireland Not yet recruiting
Dublin, Ireland
Contact: James Loughman, Prof.         
Netherlands
Erasmus University Medical Center Not yet recruiting
Rotterdam, Netherlands
Contact: Caroline Klaver, Prof.         
Portugal
University of Minho Not yet recruiting
Braga, Portugal
Contact: José Gonzlez Méijome, Prof.         
Spain
University Complutense of Madrid Recruiting
Madrid, Spain
Contact: Gonzalo Carracedo, Prof.         
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: November 29, 2021
Last Verified: November 2021
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