NCT05600140

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

July 12, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

July 12, 2022

Last Update Submit

January 5, 2026

Conditions

Keywords

viewing strategies(cerebral) visual impairmentvisual rehabilitationreading strategiesvisual search strategies

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Changes in WISC-V visual processing speed index (VSI) after training

    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

  • Changes in local visual selective attention after training

    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

  • Changes in global visual selective attention after training

    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

  • Changes in visual identification speed after training

    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

Study Arms (2)

Group A) early training group

EXPERIMENTAL

T0 = baseline measurement T1 = posttest (within two weeks after training) T2 = follow up measurement (6 months after training)

Behavioral: Viewing strategy training

Group B) late training group

EXPERIMENTAL

T0 = baseline measurement T1 = test-retest reliability and natural development (over period 1 1/2-2 months after T0) T2 = posttest (within two weeks after training)

Behavioral: Viewing strategy training

Interventions

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.

Group A) early training groupGroup B) late training group

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Dutch Visio

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Vision DisordersVision, LowBlindness, Cortical

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBlindness

Study Officials

  • Bianca Huurneman, PhD

    Royal Dutch Visio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bianca Huurneman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

October 31, 2022

Study Start

October 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations