MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigatio

Recruiting

• Conditions: 10047518; Nearsightedness

• Registration Number: NL-OMON52343
• Lead Sponsor: Dopavision GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

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, ADHD, Parkinson Disease, and autism spectrum
disorders)
- Medication affecting dopamine function, accommodation, pupil size, or having
an impact on the ocular surface (topical ocular medications)
- Participation in other clinical studies
- Medical history (or family history) of photosensitive epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in spherical equivalent refraction and axial length from baseline to 6<br /><br>months </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>