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Oculomotor Training Improves Reading Eye Movement

Primary Purpose

Ocular Motility Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oculomotor training
placebo
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Motility Disorders focused on measuring reading eye movement

Eligibility Criteria

8 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Reported by teachers or parents to have reading difficulties and failed to meet the Taylor reading eye movement norms when tested with the Visagraph III (below age norm for both fixation and regression number).
  • Studying in mainstream primary schools (8-9 years of age)
  • With normal near visual acuities for both eyes (with or without spectacles)
  • Hyperopia below +4.00 D
  • Myopia below -4.00 D
  • Astigmatism below -2.00 D
  • Anisometropia less than 2.0 D difference between the two eyes
  • Near heterophoria within 0-4 exophoria
  • Vertical heterophoria less than 1 prism dioptre
  • Monocular amplitude of accommodation over 10 D in both eyes
  • With parents who were willing to perform vision therapy exercises for the children at home on a regular basis
  • Both genders were acceptable as Eden et al (1994) stated that gender had no effect on oculomotor skills

Exclusion criteria:

  • With strabismus
  • Presence of eye diseases
  • History of dyslexia (learning disability) or developmental delay

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    experimental

    control

    Arm Description

    oculomotor training

    placebo vision training exercises

    Outcomes

    Primary Outcome Measures

    Change in number of fixation and regression during reading after 8 weeks of oculomotor training
    number of fixation and regression is measured by Visagraph per 100 words

    Secondary Outcome Measures

    Change in reading rate during reading after 8 weeks of oculomotor training
    reading rate in number of words/min and fixation duration measured in seconds
    Change in perceptual span (words per fixation) during reading after 8 weeks of oculomotor training
    perceptual span measured in words per fixation
    Change in fixation duration (seconds) during reading after 8 weeks of oculomotor training
    fixation duration measured in seconds
    Change in symptom scores after 8 weeks of oculomotor training
    symptom scores is calculated with a scale of 0 to 4 for all the 8 items of manifested symptoms

    Full Information

    First Posted
    August 17, 2016
    Last Updated
    August 2, 2020
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02981875
    Brief Title
    Oculomotor Training Improves Reading Eye Movement
    Official Title
    Oculomotor Training Improves Reading Eye Movement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    September 30, 2016 (Actual)
    Study Completion Date
    September 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Children with reading eye movement problems were recruited for this study. The treatment group was provided with oculomotor training for 8 weeks, the control group was given placebo exercises.
    Detailed Description
    Purpose of study Reading is one of the integral elements for learning and poor readers were reported to have less efficient reading eye movements. They were typically characterized by having higher number in fixation and regression, reduced reading speed and perceptual span. The purpose of this study was to investigate if vision therapy which limited to training of oculomotor skills can improve reading eye movement. Methodology This was a randomized, prospective study. 30 subjects aged from 8-9 years of age with reading difficulties and reading eye movement problems were recruited. They all have normal intelligence and ocular health, but failed to meet the Taylor reading eye movement norms when tested with the Visagraph III. The subjects were randomly assigned into either the treatment group (15) or the control group (15). The treatment group had to go through a course of oculomotor vision therapy and the control group was given placebo exercises. Vision therapy for the treatment group involved 8 weeks of training (office training - 3 times a week, 30 min per session; home training - 4 times a week, 30 min per session). Office training involved the use of Vis-Flex (Visual Flexibility Trainer - an electronic device with L.E.D. lights which can display various flashing patterns at variable speeds). Home training involved several saccadic eye movement exercises. Subjects and parents were also asked to grade the reading symptoms checklist before and after the training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ocular Motility Disorders
    Keywords
    reading eye movement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental
    Arm Type
    Experimental
    Arm Description
    oculomotor training
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    placebo vision training exercises
    Intervention Type
    Other
    Intervention Name(s)
    oculomotor training
    Intervention Description
    a sequence of vision training exercises which focused mainly in oculomotor skill
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    placebo vision training exercises involving minimal accommodation and vergence eye movement.
    Primary Outcome Measure Information:
    Title
    Change in number of fixation and regression during reading after 8 weeks of oculomotor training
    Description
    number of fixation and regression is measured by Visagraph per 100 words
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Change in reading rate during reading after 8 weeks of oculomotor training
    Description
    reading rate in number of words/min and fixation duration measured in seconds
    Time Frame
    8 weeks
    Title
    Change in perceptual span (words per fixation) during reading after 8 weeks of oculomotor training
    Description
    perceptual span measured in words per fixation
    Time Frame
    8 weeks
    Title
    Change in fixation duration (seconds) during reading after 8 weeks of oculomotor training
    Description
    fixation duration measured in seconds
    Time Frame
    8 weeks
    Title
    Change in symptom scores after 8 weeks of oculomotor training
    Description
    symptom scores is calculated with a scale of 0 to 4 for all the 8 items of manifested symptoms
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Reported by teachers or parents to have reading difficulties and failed to meet the Taylor reading eye movement norms when tested with the Visagraph III (below age norm for both fixation and regression number). Studying in mainstream primary schools (8-9 years of age) With normal near visual acuities for both eyes (with or without spectacles) Hyperopia below +4.00 D Myopia below -4.00 D Astigmatism below -2.00 D Anisometropia less than 2.0 D difference between the two eyes Near heterophoria within 0-4 exophoria Vertical heterophoria less than 1 prism dioptre Monocular amplitude of accommodation over 10 D in both eyes With parents who were willing to perform vision therapy exercises for the children at home on a regular basis Both genders were acceptable as Eden et al (1994) stated that gender had no effect on oculomotor skills Exclusion criteria: With strabismus Presence of eye diseases History of dyslexia (learning disability) or developmental delay
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carly SY Lam
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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