The VAT project is set out to prove that this approach is superior and that the Quality of Life of children with amblyopia might be significantly improved in comparison to occlusion therapy.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual acuity as measured in logmar lines
Secondary outcome
Compliance
Background summary
3 to 5% of children in the Western world have amblyopia, popularly referred to
as "lazy eye".
Amblyopia is the most common cause of unilateral visual impairment in children
and young adults and results from impaired visual development in the first
years of life.
Amblyopia is primarily a neurological defect: the part of the brain that
processes visual
signals is insufficiently stimulated by an incomplete development of the
relevant neural
network between the (lazy) eye and the brain. People with amblyopia therefore
have
difficulty with the perception of depth and forming 3D models of the world
around them.
The current treatment is occlusion: masking the good eye for a number of hours
per day,
often over a period of a few years. There are a number of drawbacks to this
treatment.
The moment an eyepatch is applied the child becomes instantly visually
impaired. This
reduces the child's quality of life. Faithfully maintaining the therapy is
therefore not easy
and this can be seen in the adherence data (<50%).
Based on an increased understanding of the cortical processes underlying
amblyopia, new treatment approaches have been studied. These new approaches are
based on simultaneous binocular visual stimulation and aim to improve visual
acuity in the amblyopic eye, but also to promote binocularity. Efforts are
being made to make these treatments appealing to children. The Vedea Amblyopia
Treatment (VAT) combines mobile VR technology with an extensive gaming library.
By playing adapted games and exercises, the "lazy eye" is activated. Studies
show that this treatment is faster and more effective than occlusion. The Vedea
solution aims to shorten the total treatment process while reducing daily
therapy from hours per day to 30 minutes.
Study objective
The VAT project is set out to prove that this approach is superior and that the
Quality of Life of children with amblyopia might be significantly improved in
comparison to occlusion therapy.
Study design
Randomised, partial cross-over, comparative design
Intervention
Use of the VAT for 16 straight weeks for 30 minutes of play per day
Study burden and risks
The American Academy of Ophthalmology has currently no evidence that too much
screen time has permanent negative consequences for eye health and the
development of the developing visual system. There is one study specifically
aimed at researching the risk of VR in young children that concludes that no
such (substantial) risks are present during, straight after and one week after
playing two 30-minute sets of very high-risk gameplay.
Erich Salomonstraat 480
Amsterdam 1087JA
NL
Erich Salomonstraat 480
Amsterdam 1087JA
NL
Listed location countries
Age
Inclusion criteria
informed consent
aged between 4 and 10 years old
wearing full corrected refraction for >=14 weeks
diagnosed with an unilateral anisometric, strabismic and/or deprivation
amblyopia
currently under treatment or starting treatment for unilateral amblyopia
access to an Android device equal to or higher than a Samsung Galaxy S8
Exclusion criteria
current treatment with atropine penalisation
documented history of severe negative side effects that occur with exposure to
VR usage (eg. seizures or epileptic spasms)
photosensitivity
no developmental delay
coexisting ocular pathology or systemic diseases
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL79107.000.22 |