An interventional study of MyopiaX and Myopia control spectacles in Myopia, sponsored by Dopavision GmbH. Completed at 10 sites in 5 countries. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Dopavision GmbH · Not applicable, Interventional, and Treatment
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.
1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 803 interventional studies indexed under Myopia.
Browse Myopia studies →This is the only study on the registry with Dopavision GmbH as lead sponsor.
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Exclusion Criteria:
MyopiaX treatment
Device: MyopiaX
Clinically validated treatment to control myopia
Device: Myopia control spectacles
MyopiaX treatment twice a day
To be used all as prescribed
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.
Time frame: 6 months
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
Time frame: 12 months
Retinal and choroidal imaging parameters
Retinal and choriodal parameters during the course of the trial
Time frame: 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
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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