MyopiaX-1
Research type
Research Study
Full title
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
IRAS ID
322733
Contact name
Annegret Dahlmann-Noor
Contact email
Sponsor organisation
Dopavision GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Myopia occurs when the eye grows too long causing far away objects to appear blurred. Children with myopia are prescribed corrective spectacles by their ophthalmologist to correct their vision. While standard corrective spectacles are an easy way to help children see far away objects more clearly, they do not prevent further myopia progression. Myopia is associated with an increased risk of vision problems in adulthood and can even lead to permanent vision loss. Therefore, it is important to develop interventions to slow myopia progression.
The purpose of this clinical trial is to investigate the safety, tolerability, and signals of effect of a new non-invasive treatment for myopia control called MyopiaX. The aim of MyopiaX is to slow the progression of myopia in children using a scientifically developed light stimulus and a child-friendly virtual reality game.
Participants are randomised to receive either the MyopiaX treatment or myopia control spectacles for 12 months. During the trial period visits at 1 month, 3 months, 6 months, and 12 months after enrolment will occur for in-depth ophthalmological examinations to check the health of the participants eyes and to measure myopia progression.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0006
Date of REC Opinion
13 Feb 2023
REC opinion
Further Information Favourable Opinion