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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyopiaX | Experimental | MyopiaX treatment |
|
| Myopia control spectacles | Active Comparator | Clinically validated treatment to control myopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyopiaX | Device | MyopiaX treatment twice a day |
| |
| Myopia control spectacles |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in axial length and in spherical equivalent refractive error | Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12 | 12 months |
| Retinal and choroidal imaging parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Flitcroft, Prof. | Centre for Eye Reserach Ireland, Technological University Dublin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suedblick GmbH | Augsburg | Germany | ||||
| BeyondEye Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41438818 | Derived | 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. |
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| Device |
To be used all as prescribed |
|
Retinal and choriodal parameters during the course of the trial
| 12 months |
| Device usability as measured with the user feedback questionnaire | Device usability as measured with the user feedback questionnaire at the end of the study | 12 months |
| Cologne |
| Germany |
| MVZ Makula-Netzhaut-Zentrum Breyer Kaymak Klabe | Düsseldorf | 40549 | Germany |
| University Medical Center, Johannes Gutenberg- University | Mainz | Germany |
| University Eye Hospital Tübingen | Tübingen | Germany |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| University of Minho | Braga | Portugal |
| Hospital Sant Joan de Déu | Barcelona | Spain |
| University Complutense of Madrid | Madrid | Spain |
| Moorfields Eye Hospital NHS Fundation Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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