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 efficient…
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p>The following parameters will be analyzed:<br />
- The use of a structured viewing strategy (qualitative analysis)<br />
- Saccade amplitudes as measured during reading and visual search<br />
- Fixation behavior (spatial and temporal) during search and reading<br />
- Reading accuracy and speed<br />
- Visual search accuracy and speed</p>
Secondary outcome
<p>The secondary study parameters for the intervention study are:<br />
- WISC-V visual processing speed index<br />
- Tea-Ch Speurtocht<br />
- Gestalt Closure (subtest Kaufman-ABC-II)<br />
- Plaatjes Benoemen (subtest DST-NL)</p>
Background 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.
Study objective
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 efficient visual information processing.
Study design
Stage 1) Observational (case control design), Stage 2) Non-RCT.
Intervention
In the second stage 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.
Study burden and risks
Children with visual impairment will visit Royal Dutch Visio one time for the first study. The measurements are added to the standard orthoptic testing that is performed and will take approximately 20 minutes. Normal controls will be recruited and tested at regular schools and also undergo a short visual exam in addition to five short tasks (three visual taks: the reading and search tasks, and two short verbal tasks (total time 35-50 minutes)). For the second study, children will visit the centre three times. The pre- and posttest consists of a number of neuropsychological paper-and-pencil tasks and
three tasks on the eye-tracker (reading and two search tasks) and will take about 50 minutes. Training sessions will be performed at home or at school under supervision of occupational therapists.
B. Huurneman
Javastraat 104
Nijmegen 6524 MJ
Netherlands
0623901048
biancahuurneman@visio.org
B. Huurneman
Javastraat 104
Nijmegen 6524 MJ
Netherlands
0623901048
biancahuurneman@visio.org
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Inclusion criteria typically developing children with normal vision:
• Age 5-12 years
• linear distant visual acuity of 0.1 logMAR or better
• No (suspicion of) intellectual impairment (e.g. verbal IQ below 70)
• No diagnosis or suspicion 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)
• No (suspicion of) intellectual impairment (e.g. verbal IQ below 70)
• No diagnosis or suspicion 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)
• No (suspicion of) intellectual impairment (e.g. verbal IQ below 70)
• No diagnosis or suspicion of developmental disorders or 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. Age range study 2: 5-9 years.
Exclusion criteria
• Children with VI: linear near visual acuity >1.0 logMAR
• Children with visual field defect < 30 degrees
• Children with (suspected) intellectual impairment
• Children with (suspected) psychiatric problems like ASS or AD(H)D
• Auditory impairment or language impairments
• Major life events (expected) during training
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| ClinicalTrials.gov | NCT05600140 |
| CCMO | NL81584.091.22 |
| Research portal | NL-006955 |