Clinical trial NCT05600140: Viewing Strategy Training in Children With (Cerebral) Visual Impairment
Official title: Viewing Strategy Training in Children With (Cerebral) Visual Impairment: From Spontaneous Eye Movements to a Structured Viewing Strategy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vision Disorders
Vision, Low
Keywords: viewing strategies
(cerebral) visual impairment
visual rehabilitation
reading strategies
visual search strategies
Lead sponsor: Royal Dutch Visio
Sponsor class: OTHER
Collaborators: name: Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands
First posted: 2022-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the first phase of the study, we aim to include 48 children aged 5-12 years for each group (i.e. normal Vision, ocular visual impairment, cerebral visual impairment). For the second phase of the study 60 children with visual impairment aged 5-9 years will be included (ocular impairment: n=30, cerebral visual impairment: n=30).

In the second phase of the project, children receive a visual training of viewing strategies (six weeks, 2 times a week, 30 minutes). During the training, children are instructed to use specific viewing strategies (looking in a structured direction which fits the task at hand, zooming in and out / change of visual selective attentional field, visual discrimination). The verbal instructions and exercises are protocol based. A textbook is used to describe the reactions of the children during training.
Primary purpose: TREATMENT

Brief summary: Viewing strategies are strategies used to process visual Information. Many children with visual impairment seem to lack systematic viewing strategies. However, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. In addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach.

The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI, and (2) to evaluate whether training viewing strategies results in more efficiënt visual Information processing.


Eligibility criteria: Inclusion criteria typically developing children with normal vision:

* Age 5-12 years
* linear distant visual acuity of 0.1 logMAR or better
* Verbal IQ above 70
* Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with ocular visual impairment:

* Age 5-12 years
* Children with linear distance visual acuity better \<=1.3logMAR and \>0.1 logMAR
* Intact central visual field (at least \> 30 degrees)
* Children with a verbal IQ above 70
* Absence of developmental disorders or psychiatric problems like ASS or AD(H)D

Inclusion criteria for children with cerebral visual impairment:

* Age 5-12 years
* Linear distance visual acuity \<=0.3 logMAR
* Having the diagnosis CVI (verified by ophthalmologists)
* Children with a verbal IQ above 70
* Absence of psychiatric problems like ASS or AD(H)D

Additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. Training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). The age range for study 2 is 5-9 years.

Exclusion criteria:

* Children with VI: linear near visual acuity \>1.0 logMAR
* Children with visual field defect \< 30 degrees
* Children with a verbal IQ below 70
* Children who attended a form of vision training in the past two years
* Children with psychiatric problems like ASS or AD(H)D
* Auditory impairment or language impairments
* Major life events during training

Primary outcomes:
measure: Changes in reading accuracy after viewing strategy training
timeFrame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
measure: Changes in reading speed after viewing strategy training
timeFrame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
measure: Changes in visual search accuracy after training
timeFrame: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
measure: Changes in visual search speed after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in saccade amplitudes during reading and visual search after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in fixation duration during reading and search after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in average distance between fixation points during conjunction search (EB-VSA) after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Secondary outcomes:
measure: Changes in WISC-V visual processing speed index (VSI) after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in local visual selective attention after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in global visual selective attention after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
measure: Changes in visual identification speed after training
timeFrame: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Royal Dutch Visio
Study officials:
affiliation: Royal Dutch Visio
name: Bianca Huurneman, PhD
role: PRINCIPAL_INVESTIGATOR
References: