None listed
Conditions
Brief summary
Melanopsin is expressed by axons of intrinsically photosensitive retinal ganglion cells (ipRGC) that pass through the optic nerve head, corresponding to the blind spot. Blue light stimulation of the blind spot has been demonstrated to activate melanopsin. The synaptic pathway between ipRGCs and dopaminergic amacrine cells in the retina has implicated these cells in the light-mediated mechanisms regulating eye growth. This human experimental study addresses the hypothesis that the biomarker choroidal thickness increases with repeated daily blue light stimulation of the blind spot over a seven-day period as compared to red light stimulation in myopic children and adolescents.
Interventions
The research study addresses short-term effects of MyopiaX on so-called clinical biomarkers. MyopiaX is a digital application that delivers flickering light to the blind spot of the eye while using a smartphone-compatible game. The smartphone with the installed app is set into a virtual reality headset and the game is played with a controller. The biomarkers are choroidal thickness and axial length. Both parameters will be non-invasively measured by common and clinically approved techniques in t
The research study addresses short-term effects of MyopiaX on so-called clinical biomarkers. MyopiaX is a digital application that delivers flickering light to the blind spot of the eye while using a smartphone-compatible game. The smartphone with the installed app is set into a virtual reality headset and the game is played with a controller. The biomarkers are choroidal thickness and axial length. Both parameters will be non-invasively measured by common and clinically approved techniques in the eyes of the volunteers after usage of blue or red light stimulation of one week each. The light stimulus is carefully positioned using a virtual reality headset. Volunteers will play a virtual reality game for the length of the stimulation session. MyopiaX is a non-invasive intervention. Volunteers will be trained on the device MyopiaX before the first stimulation period. Detailed instructions and demonstration are provided to the volunteer by the investigators (optometrist) and will enable the volunteer to apply the preset stimulation independently at home. Participants are provided with the device with the appropriate light settings (blue light or red light) at each visit. In the randomized, controlled, 3-period crossover study, volunteers will apply blue light stimulation to the blind spots (optic nerve head) of both eyes for 100 s once daily (1Blue), twice daily (2Blue), or red light stimulation once daily (Red) for seven days each. The order of conditions will be randomized. Stimulation periods are separated by two washout periods of one week duration each.
Sponsors
Dopavision GmbH
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Male or female volunteers aged between 6 and 16 years. Documented diagnosis of myopia as characterized by spherical equivalent refraction ranging from -0.5 to -6.0 D inclusive. Corrected visual acuity of at least 0.2 logMAR in each eye. Good tolerability of test session with the VR system. Binocular adequacy as tested with VR. Ability to understand and give assent.
Exclusion criteria
Not habitually corrected for myopia. Concomitant therapies for control of myopia progression. Former myopia interventions within the following washout periods: - Low-dose atropine eyedrops within the last 3 months. - Orthokeratology contact lenses within the last 3 months. Eye diseases/conditions such as - Anisometropia of at least 1.5 D - Astigmatism of at least 3 D - Ophthalmological comorbidities - Optic nerve abnormalities - Suspicion of syndromic or monogenetic myopia Systemic illnesses affecting eye health. Any illnesses affecting dopamine function (such as sleep disorder, ADHD, Parkinson’s 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.
Outcome results
None listed