Trials / Completed
CompletedNCT04967287
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Dopavision GmbH · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MyopiaX | MyopiaX treatment twice a day |
| DEVICE | Myopia control spectacles | To be used all as prescribed |
Timeline
- Start date
- 2021-11-16
- Primary completion
- 2024-10-04
- Completion
- 2024-10-04
- First posted
- 2021-07-19
- Last updated
- 2024-10-28
Locations
10 sites across 5 countries: Germany, Netherlands, Portugal, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04967287. Inclusion in this directory is not an endorsement.