MyopiaMyopiaX-1NCT04967287
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
A study testing MyopiaX in people with Myopia, run by Dopavision GmbH at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- MyopiaX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 16 Nov 2021to 4 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Concomitant or previous therapies for myopia
- Eye diseases/conditions:
- Anisometropia ≥ 1.5 D
- Astigmatism ≥ 3 D
- Ophthalmological comorbidities
- Optic nerve abnormalities
Show all 12Show fewer
- 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
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany5 sites
Suedblick GmbH
Augsburg
BeyondEye Clinic
Cologne
MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
Düsseldorf, 40549
University Medical Center, Johannes Gutenberg- University
Mainz
University Eye Hospital Tübingen
Tübingen
Spain2 sites
Hospital Sant Joan de Déu
Barcelona
University Complutense of Madrid
Madrid
United Kingdom1 site
Moorfields Eye Hospital NHS Fundation Trust
London
About this study
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- MyopiaX, Myopia control spectacles
- Keywords
- Digital treatment
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyopiaXDevice
MyopiaX treatment twice a day
Myopia control spectaclesDevice
To be used all as prescribed
| Study group | Role | What they receive |
|---|---|---|
| MyopiaX | Experimental | MyopiaX treatment Receives: Device: MyopiaX |
| Myopia control spectacles | Active comparator | Clinically validated treatment to control myopia Receives: Device: Myopia control spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start16 Nov 2021
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dopavision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian Flitcroft, Prof., Study chair, Centre for Eye Reserach Ireland, Technological University Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967287
- Sponsor's protocol ID
- MyopiaX-1
- Acronym
- MyopiaX-1
- Status last verified
- Oct 2024
- First submitted
- 7 Jul 2021
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loughman J, Lingham G, Kaymak H, Lorenz K, Polling JR, Beck A, Carracedo G, Dahlmann-Noor AH, Muller PL, Flitcroft I; MyopiaX-1 Study Group. MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial. Ophthalmol Sci. 2025 Oct 10;6(1):100973. doi: 10.1016/j.xops.2025.100973. eCollection 2026 Jan.
PubMed 41438818
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
- ClinicalTrials.gov ID
- NCT04967287
- Acronym / sponsor ID
- MyopiaX-1 / MyopiaX-1
- Conditions
- Myopia
- Keywords
- Digital treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Dopavision GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyopiaX | Experimental | Device: MyopiaXMyopiaX treatment |
| Myopia control spectacles | Active comparator | Device: Myopia control spectaclesClinically validated treatment to control myopia |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Concomitant or previous therapies for myopia
- Eye diseases/conditions:
- Anisometropia ≥ 1.5 D
- Astigmatism ≥ 3 D
- Ophthalmological comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyopiaXMyopiaX treatment twice a day | Device | MyopiaX |
| Myopia control spectaclesTo be used all as prescribed | Device | Myopia control spectacles |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Derived from this study: PubMed 41438818Loughman J, Lingham G, Kaymak H, Lorenz K, Polling JR, Beck A, Carracedo G, Dahlmann-Noor AH, Muller PL, Flitcroft I; MyopiaX-1 Study Group. MyopiaX-1 Safety and Efficacy of a Novel Approach to Slow Juvenile Myopia Progression: A Multicenter, Randomized, Controlled Trial. Ophthalmol Sci. 2025 Oct 10;6(1):100973. doi: 10.1016/j.xops.2025.100973. eCollection 2026 Jan.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Flitcroft, Prof. study chair
Centre for Eye Reserach Ireland, Technological University Dublin
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyopiaX in people with Myopia, run by Dopavision GmbH at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain, Netherlands, Portugal, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length and in spherical equivalent refractive error (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.