The first goal of the PLING-project is to improve the clinical applicability of the training by developing a home-based app that can be on any Windows or Mac system. The second goal is to optimize training gain by: 1) increasing the number of…
ID
Source
Brief title
Condition
- Congenital eye disorders (excl glaucoma)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intervention study + validation study:
- Near and distance visual acuity
- Crowding intensity
Secondary outcome
Intervention study:
- Contrast sensitivity function
- Stereopsis
- Reading performance
- Eye movements (fixation stability and saccade execution)
- Compliance
- Training joy
- Vision related quality of life
Background summary
Infantile nystagmus (IN) is characterized by the presence of involuntary,
oscillating eye movements with an onset in the first six months of life. The
prevalence of IN is 1.4 per 1000. IN is associated with suboptimal vision and
affects the quality of life. Recently we developed a computerized training
which successfully improves vision in children with IN. Ten training sessions
resulted in a vision improvement of ~30%, a stereopsis gain of 66% and improved
reading performance. Performance improvements were not only visible on the
trained task, but were also present on non-trained tasks.
Study objective
The first goal of the PLING-project is to improve the clinical applicability of
the training by developing a home-based app that can be on any Windows or Mac
system. The second goal is to optimize training gain by: 1) increasing the
number of training sessions, and 2) combining training conditions. The third
goal is to conduct a follow up measurement 6 months after training. In addition
to the development of the training app (intervention study), we will also
validate a newly developed crowding app (validation study).
Study design
Intervention study: One-armed pretest-posttest design.
Validation study: Prospective cohort study.
Intervention
Intervention study: Computerized visual perceptual learning.
Study burden and risks
Intervention study: Children will visit the vision rehabilitation centre 3
times. Each measurement will take approximately 45 minutes. In addition,
children have to adhere to the protocol. Children will not miss any school
appointments and can use the training at home. It is very likely that children
will benefit from the training, since we this approach resulted in 0.10-0.15
logMAR gains in visual acuity before (see Huurneman et al. IOVS
2016;57(10):4216-4246). There are no risks associated with the treatment. In
our previous study, children indicated that they enjoyed the training (measured
with a 'smiley' score).
Validation study: Because the measurements in the group of children with
infantile nystagmus are already quite extensive, we have chosen to approach a
new set of participants with normal vision for the validation study. Children
with normal vision are seen only once at school for 30-45 minutes.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
Children with infantile nystagmus:
- Age 7-18 years
- Diagnosis albinism (with infantile nystagmus) or idiopathic infantile nystagmus
- Binocular visual acuity >=20/400 and < 20/20.
- No additional (neurological or motor) impairments
- Born at term with normal birth weight (>=3000 gr);Children with normal vision:
- Age 8-18 years (n = 30)
- Binocular visual acuity >=20/20
- Born at term (>30 weeks) with normal birth weight (>3000 gr)
Exclusion criteria
Children with infantile nystagmus:
- Received computerized visual perceptual learning before
- Neurological conditions such as cerebral visual impairment, oculomotor apraxia, hemianopia, developmental disorders.
- Visual acuity <20/400 or >= 20/20. ;Children with normal vision:
- Motor or mental impairments;
- The presence of a developmental disorder;
- Binocular visual acuity <20/20.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61860.091.17 |
| OMON | NL-OMON26659 |