MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation (MyopiaX-1)
Primary Purpose
Myopia
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MyopiaX
Myopia control spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Digital treatment
Eligibility 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
Sites / Locations
- Suedblick GmbH
- MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
- BeyondEye Clinic
- University Medical Center, Johannes Gutenberg- University
- University Eye Hospital Tübingen
- Erasmus University Medical Center
- University of Minho
- Hospital Sant Joan de Déu
- University Complutense of Madrid
- Moorfields Eye Hospital NHS Fundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MyopiaX
Myopia control spectacles
Arm Description
MyopiaX treatment
Clinically validated treatment to control myopia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967287
Brief Title
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
Acronym
MyopiaX-1
Official Title
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dopavision GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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 adolescents.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Digital treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyopiaX
Arm Type
Experimental
Arm Description
MyopiaX treatment
Arm Title
Myopia control spectacles
Arm Type
Active Comparator
Arm Description
Clinically validated treatment to control myopia
Intervention Type
Device
Intervention Name(s)
MyopiaX
Intervention Description
MyopiaX treatment twice a day
Intervention Type
Device
Intervention Name(s)
Myopia control spectacles
Intervention Description
To be used all as prescribed
Primary Outcome Measure Information:
Title
Change in axial length and in spherical equivalent refractive error
Description
Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in axial length and in spherical equivalent refractive error
Description
Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12
Time Frame
12 months
Title
Retinal and choroidal imaging parameters
Description
Retinal and choriodal parameters during the course of the trial
Time Frame
12 months
Title
Device usability as measured with the user feedback questionnaire
Description
Device usability as measured with the user feedback questionnaire at the end of the study
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Flitcroft, Prof.
Organizational Affiliation
Centre for Eye Reserach Ireland, Technological University Dublin
Official's Role
Study Chair
Facility Information:
Facility Name
Suedblick GmbH
City
Augsburg
Country
Germany
Facility Name
MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
City
Düsseldorf
ZIP/Postal Code
40549
Country
Germany
Facility Name
BeyondEye Clinic
City
Köln
Country
Germany
Facility Name
University Medical Center, Johannes Gutenberg- University
City
Mainz
Country
Germany
Facility Name
University Eye Hospital Tübingen
City
Tübingen
Country
Germany
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
University of Minho
City
Braga
Country
Portugal
Facility Name
Hospital Sant Joan de Déu
City
Barcelona
Country
Spain
Facility Name
University Complutense of Madrid
City
Madrid
Country
Spain
Facility Name
Moorfields Eye Hospital NHS Fundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
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