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

Sponsor
Dopavision GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04967287
Collaborator
(none)
234
Enrollment
6
Locations
2
Arms
40.4
Anticipated Duration (Months)
39
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: MyopiaX
  • Device: Sham
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 16, 2021
Anticipated Primary Completion Date :
Mar 30, 2024
Anticipated Study Completion Date :
Mar 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in spherical equivalent refraction [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 [24 months]

    Change in axial length (mm) from baseline to 24 months as measured by optical biometry

  2. Change in spherical equivalent refraction [12 months]

    Change in spherical equivalent refraction (D) from baseline to 12 months as measured by cycloplegic autorefraction

  3. Changes in axial length [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 [12 and 24 months]

    Questionnaire created to evaluate parents satisfaction with the device and treatment concept

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe Düsseldorf Germany 40549
2 University Eye Hospital Tübingen Tübingen Germany
3 Centre for Eye Research Ireland Dublin Ireland
4 Erasmus University Medical Center Rotterdam Netherlands
5 University of Minho Braga Portugal
6 University Complutense of Madrid Madrid Spain

Sponsors and Collaborators

  • Dopavision GmbH

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dopavision GmbH
ClinicalTrials.gov Identifier:
NCT04967287
Other Study ID Numbers:
  • MyopiaX-1
First Posted:
Jul 19, 2021
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Myopia

Study Results

No Results Posted as of Feb 1, 2022