search
Back to results

Viewing Strategy Training in Children With (Cerebral) Visual Impairment

Primary Purpose

Vision Disorders, Vision, Low

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Viewing strategy training
Sponsored by
Royal Dutch Visio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vision Disorders focused on measuring viewing strategies, (cerebral) visual impairment, visual rehabilitation, reading strategies, visual search strategies

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group A) early training group

    Group B) late training group

    Arm Description

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

    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)

    Outcomes

    Primary Outcome Measures

    Changes in reading accuracy after viewing strategy training
    Radner reading test
    Changes in reading speed after viewing strategy training
    Radner reading test
    Changes in visual search accuracy after training
    Accuracy during conjunction search
    Changes in visual search speed after training
    Speed during conjunction search
    Changes in saccade amplitudes during reading and visual search after training
    Saccade amplitudes measured using Radner reading test and conjunction search
    Changes in fixation duration during reading and search after training
    Fixation durations measured using Radner reading test and conjunction search
    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

    Secondary Outcome Measures

    Changes in WISC-V visual processing speed index (VSI) after training
    WISC-IV visual processing speed index
    Changes in local visual selective attention after training
    TEA-Ch Speurtocht (total number of symbols found in 1 minute)
    Changes in global visual selective attention after training
    Gestalt Closure (Kaufman-ABC), number of correct answers
    Changes in visual identification speed after training
    'DST-Plaatjes Benoemen', number of pictures correctly named within 1 minute

    Full Information

    First Posted
    July 12, 2022
    Last Updated
    March 28, 2023
    Sponsor
    Royal Dutch Visio
    Collaborators
    Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05600140
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 4, 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal Dutch Visio
    Collaborators
    Radboud University, Behavioural Science Institute, Nijmegen, The Netherlands

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vision Disorders, Vision, Low
    Keywords
    viewing strategies, (cerebral) visual impairment, visual rehabilitation, reading strategies, visual search strategies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A) early training group
    Arm Type
    Experimental
    Arm Description
    T0 = baseline measurement T1 = posttest (within two weeks after training) T2 = follow up measurement (6 months after training)
    Arm Title
    Group B) late training group
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Viewing strategy training
    Intervention Description
    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 Outcome Measure Information:
    Title
    Changes in reading accuracy after viewing strategy training
    Description
    Radner reading test
    Time Frame
    Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
    Title
    Changes in reading speed after viewing strategy training
    Description
    Radner reading test
    Time Frame
    Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
    Title
    Changes in visual search accuracy after training
    Description
    Accuracy during conjunction search
    Time Frame
    Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4
    Title
    Changes in visual search speed after training
    Description
    Speed during conjunction search
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in saccade amplitudes during reading and visual search after training
    Description
    Saccade amplitudes measured using Radner reading test and conjunction search
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in fixation duration during reading and search after training
    Description
    Fixation durations measured using Radner reading test and conjunction search
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in average distance between fixation points during conjunction search (EB-VSA) after training
    Description
    Average distance between fixation points using Radner reading test and conjunction search
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Secondary Outcome Measure Information:
    Title
    Changes in WISC-V visual processing speed index (VSI) after training
    Description
    WISC-IV visual processing speed index
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in local visual selective attention after training
    Description
    TEA-Ch Speurtocht (total number of symbols found in 1 minute)
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in global visual selective attention after training
    Description
    Gestalt Closure (Kaufman-ABC), number of correct answers
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4
    Title
    Changes in visual identification speed after training
    Description
    'DST-Plaatjes Benoemen', number of pictures correctly named within 1 minute
    Time Frame
    Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bianca Huurneman, PhD
    Phone
    0(031)646944002
    Email
    biancahuurneman@visio.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bianca Huurneman, PhD
    Organizational Affiliation
    Royal Dutch Visio
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Viewing Strategy Training in Children With (Cerebral) Visual Impairment

    We'll reach out to this number within 24 hrs