Viewing Strategy Training in Children With (Cerebral) Visual Impairment

Vision Disorders Clinical Trial

Official title:

Viewing Strategy Training in Children With (Cerebral) Visual Impairment: From Spontaneous Eye Movements to a Structured Viewing Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05600140
• Other study ID #: NL81584.091.22
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Royal Dutch Visio
• Contact: Bianca Huurneman, PhD
• Phone: 0(031)646944002
• Email: biancahuurneman[@]visio.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low

Intervention

Behavioral:
• Viewing strategy training
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.

Locations

Country	Name	City	State
Netherlands	Royal Dutch Visio	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Royal Dutch Visio	Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in reading accuracy after viewing strategy training	Radner reading test	Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
Primary	Changes in reading speed after viewing strategy training	Radner reading test	Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
Primary	Changes in visual search accuracy after training	Accuracy during conjunction search	Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
Primary	Changes in visual search speed after training	Speed during conjunction search	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Primary	Changes in saccade amplitudes during reading and visual search after training	Saccade amplitudes measured using Radner reading test and conjunction search	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Primary	Changes in fixation duration during reading and search after training	Fixation durations measured using Radner reading test and conjunction search	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Primary	Changes in average distance between fixation points during conjunction search (EB-VSA) after training	Average distance between fixation points using Radner reading test and conjunction search	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Secondary	Changes in WISC-V visual processing speed index (VSI) after training	WISC-IV visual processing speed index	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Secondary	Changes in local visual selective attention after training	TEA-Ch Speurtocht (total number of symbols found in 1 minute)	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Secondary	Changes in global visual selective attention after training	Gestalt Closure (Kaufman-ABC), number of correct answers	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
Secondary	Changes in visual identification speed after training	'DST-Plaatjes Benoemen', number of pictures correctly named within 1 minute	Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4