Trial Review

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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
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
Secondary ID [1] 310368 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 331112 0
Condition category
Condition code
Eye 327897 327897 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326770 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 335741 0
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.
Timepoint [1] 335741 0
7 days post commencement of each stimulation period (1Blue, 2Blue, Red).
Secondary outcome [1] 425431 0
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.
Timepoint [1] 425431 0
7 days post commencement of each stimulation period (1Blue, 2Blue, Red).
Secondary outcome [2] 425814 0
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.
Timepoint [2] 425814 0
7 days post commencement of each stimulation period (1Blue, 2Blue, Red).

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.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
28/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314573 0
Commercial sector/Industry
Name [1] 314573 0
Dopavision GmbH
Country [1] 314573 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Dopavision GmbH
Address
Krausenstrasse 9-10
D-10117 Berlin
Country
Germany
Secondary sponsor category [1] 316535 0
None
Name [1] 316535 0
Address [1] 316535 0
Country [1] 316535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313607 0
Queensland University of Technology, University Human Research Ethics Committee
Ethics committee address [1] 313607 0
2 George Street
QLD 4000 Brisbane
Ethics committee country [1] 313607 0
Australia
Date submitted for ethics approval [1] 313607 0
09/08/2023
Approval date [1] 313607 0
11/09/2023
Ethics approval number [1] 313607 0
7443

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128730 0
Prof Michael Collins
Address 128730 0
School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
Country 128730 0
Australia
Phone 128730 0
+61413246913
Fax 128730 0
Email 128730 0
m.collins@qut.edu.au
Contact person for public queries
Name 128731 0
Prof Michael Collins
Address 128731 0
School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
Country 128731 0
Australia
Phone 128731 0
+61413246913
Fax 128731 0
Email 128731 0
m.collins@qut.edu.au
Contact person for scientific queries
Name 128732 0
Prof Michael Collins
Address 128732 0
School of Optometry and Vision Science
Contact Lens & Visual Optics Laboratory
Queensland University of Technology
Victoria Park Road
4059 Brisbane
Queensland
Country 128732 0
Australia
Phone 128732 0
+61413246913
Fax 128732 0
Email 128732 0
m.collins@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.