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Trial registered on ANZCTR
Registration number
ACTRN12623000928617
Ethics application status
Approved
Date submitted
14/08/2023
Date registered
29/08/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of blue light stimulation of the optic nerve head on choroidal thickness and axial length in children with myopia
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Scientific title
A randomized, controlled, 3-period crossover study to evaluate short-term effects of blue light stimulation of the optic nerve head with the device MyopiaX on the clinical biomarkers choroidal thickness and axial length in children and adolescents with myopia
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Secondary ID [1]
310368
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myopia
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Condition category
Condition code
Eye
327897
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
326770
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Treatment: Devices
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Comparator / control treatment
Volunteers will apply red light stimulation to the blind spots (optic nerve head) of both eyes for 100 s once daily (Red) for seven days as control intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change of choroidal thickness (ChT) assessed by optical coherence tomography (OCT) and calculated for each stimulation period by subtraction of the absolute ChT before the stimulation from the absolute ChT after the corresponding 7-days stimulation period.
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Assessment method [1]
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Timepoint [1]
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7 days post commencement of each stimulation period (1Blue, 2Blue, Red).
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Secondary outcome [1]
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Safety: Incidence of SAEs and AEs.
Application of light stimulation with MyopiaX has the potential to cause adverse effects or discomforts and in some cases may be associated with dry eyes, eye strain, headache or increased light sensitivity. These symptoms should be transient and mild. The investigators will inquire potential adverse events at each visit.
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Assessment method [1]
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Timepoint [1]
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7 days post commencement of each stimulation period (1Blue, 2Blue, Red).
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Secondary outcome [2]
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Change of axial length (AxL) assessed by optical low coherence reflectometry and
calculated for each stimulation period by subtraction of the absolute AxL before the treatment from the absolute AxL after the corresponding 7-days treatment period.
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Assessment method [2]
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Timepoint [2]
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7 days post commencement of each stimulation period (1Blue, 2Blue, Red).
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Eligibility
Key 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.
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Minimum age
6
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/10/2023
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Actual
28/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
18
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Accrual to date
9
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Dopavision GmbH
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Address [1]
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Krausenstrasse 9-10
D-10117 Berlin
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Country [1]
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Germany
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Primary sponsor type
Commercial sector/Industry
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Name
Dopavision GmbH
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Address
Krausenstrasse 9-10
D-10117 Berlin
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Country
Germany
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
316535
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Queensland University of Technology, University Human Research Ethics Committee
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Ethics committee address [1]
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2 George Street
QLD 4000 Brisbane
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Ethics committee country [1]
313607
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Australia
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Date submitted for ethics approval [1]
313607
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09/08/2023
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Approval date [1]
313607
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11/09/2023
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Ethics approval number [1]
313607
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7443
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Michael Collins
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Address
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School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
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Country
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Australia
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Phone
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+61413246913
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Michael Collins
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Address
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School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
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Country
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Australia
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Phone
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+61413246913
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Michael Collins
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Address
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School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
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Country
128732
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Australia
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Phone
128732
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+61413246913
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Fax
128732
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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