Myopia
Conditions
Keywords
Digital treatment
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.
Interventions
DEVICEMyopiaX
MyopiaX treatment twice a day
To be used all as prescribed
Sponsors
Dopavision GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in axial length and in spherical equivalent refractive error | 6 months | Change in axial length (mm) and in spherical equivalent refractive error )D)from baseline to month 6. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in axial length and in spherical equivalent refractive error | 12 months | Change in axial length (mm) and spherical equivalent refractive error (D) from month 6 to month 12 |
| Retinal and choroidal imaging parameters | 12 months | Retinal and choriodal parameters during the course of the trial |
| Device usability as measured with the user feedback questionnaire | 12 months | Device usability as measured with the user feedback questionnaire at the end of the study |
Countries
Germany, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed