<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981875</url>
  </required_header>
  <id_info>
    <org_study_id>HongKongPUVT</org_study_id>
    <nct_id>NCT02981875</nct_id>
  </id_info>
  <brief_title>Oculomotor Training Improves Reading Eye Movement</brief_title>
  <official_title>Oculomotor Training Improves Reading Eye Movement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children with reading eye movement problems were recruited for this study. The treatment&#xD;
      group was provided with oculomotor training for 8 weeks, the control group was given placebo&#xD;
      exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of study Reading is one of the integral elements for learning and poor readers were&#xD;
      reported to have less efficient reading eye movements. They were typically characterized by&#xD;
      having higher number in fixation and regression, reduced reading speed and perceptual span.&#xD;
      The purpose of this study was to investigate if vision therapy which limited to training of&#xD;
      oculomotor skills can improve reading eye movement.&#xD;
&#xD;
      Methodology This was a randomized, prospective study. 30 subjects aged from 8-9 years of age&#xD;
      with reading difficulties and reading eye movement problems were recruited. They all have&#xD;
      normal intelligence and ocular health, but failed to meet the Taylor reading eye movement&#xD;
      norms when tested with the Visagraph III. The subjects were randomly assigned into either the&#xD;
      treatment group (15) or the control group (15). The treatment group had to go through a&#xD;
      course of oculomotor vision therapy and the control group was given placebo exercises. Vision&#xD;
      therapy for the treatment group involved 8 weeks of training (office training - 3 times a&#xD;
      week, 30 min per session; home training - 4 times a week, 30 min per session). Office&#xD;
      training involved the use of Vis-Flex (Visual Flexibility Trainer - an electronic device with&#xD;
      L.E.D. lights which can display various flashing patterns at variable speeds). Home training&#xD;
      involved several saccadic eye movement exercises. Subjects and parents were also asked to&#xD;
      grade the reading symptoms checklist before and after the training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of fixation and regression during reading after 8 weeks of oculomotor training</measure>
    <time_frame>8 weeks</time_frame>
    <description>number of fixation and regression is measured by Visagraph per 100 words</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in reading rate during reading after 8 weeks of oculomotor training</measure>
    <time_frame>8 weeks</time_frame>
    <description>reading rate in number of words/min and fixation duration measured in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceptual span (words per fixation) during reading after 8 weeks of oculomotor training</measure>
    <time_frame>8 weeks</time_frame>
    <description>perceptual span measured in words per fixation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fixation duration (seconds) during reading after 8 weeks of oculomotor training</measure>
    <time_frame>8 weeks</time_frame>
    <description>fixation duration measured in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptom scores after 8 weeks of oculomotor training</measure>
    <time_frame>8 weeks</time_frame>
    <description>symptom scores is calculated with a scale of 0 to 4 for all the 8 items of manifested symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ocular Motility Disorders</condition>
  <arm_group>
    <arm_group_label>experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oculomotor training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo vision training exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>oculomotor training</intervention_name>
    <description>a sequence of vision training exercises which focused mainly in oculomotor skill</description>
    <arm_group_label>experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo vision training exercises involving minimal accommodation and vergence eye movement.</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reported by teachers or parents to have reading difficulties and failed to meet the&#xD;
             Taylor reading eye movement norms when tested with the Visagraph III (below age norm&#xD;
             for both fixation and regression number).&#xD;
&#xD;
          -  Studying in mainstream primary schools (8-9 years of age)&#xD;
&#xD;
          -  With normal near visual acuities for both eyes (with or without spectacles)&#xD;
&#xD;
          -  Hyperopia below +4.00 D&#xD;
&#xD;
          -  Myopia below -4.00 D&#xD;
&#xD;
          -  Astigmatism below -2.00 D&#xD;
&#xD;
          -  Anisometropia less than 2.0 D difference between the two eyes&#xD;
&#xD;
          -  Near heterophoria within 0-4 exophoria&#xD;
&#xD;
          -  Vertical heterophoria less than 1 prism dioptre&#xD;
&#xD;
          -  Monocular amplitude of accommodation over 10 D in both eyes&#xD;
&#xD;
          -  With parents who were willing to perform vision therapy exercises for the children at&#xD;
             home on a regular basis&#xD;
&#xD;
          -  Both genders were acceptable as Eden et al (1994) stated that gender had no effect on&#xD;
             oculomotor skills&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  With strabismus&#xD;
&#xD;
          -  Presence of eye diseases&#xD;
&#xD;
          -  History of dyslexia (learning disability) or developmental delay&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carly SY Lam</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <reference>
    <citation>Bigelow ER, McKenzie BE. Unstable ocular dominance and reading ability. Perception. 1985;14(3):329-35. doi: 10.1068/p140329.</citation>
    <PMID>4088794</PMID>
  </reference>
  <reference>
    <citation>Biscaldi M, Gezeck S, Stuhr V. Poor saccadic control correlates with dyslexia. Neuropsychologia. 1998 Nov;36(11):1189-202. doi: 10.1016/s0028-3932(97)00170-x.</citation>
    <PMID>9842764</PMID>
  </reference>
  <reference>
    <citation>Borsting EJ, Rouse MW, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in children aged 9 to 18 years. Optom Vis Sci. 2003 Dec;80(12):832-8. doi: 10.1097/00006324-200312000-00014.</citation>
    <PMID>14688547</PMID>
  </reference>
  <reference>
    <citation>Bosse ML, Tainturier MJ, Valdois S. Developmental dyslexia: the visual attention span deficit hypothesis. Cognition. 2007 Aug;104(2):198-230. doi: 10.1016/j.cognition.2006.05.009. Epub 2006 Jul 21.</citation>
    <PMID>16859667</PMID>
  </reference>
  <reference>
    <citation>Bucci MP, Nassibi N, Gerard CL, Bui-Quoc E, Seassau M. Immaturity of the oculomotor saccade and vergence interaction in dyslexic children: evidence from a reading and visual search study. PLoS One. 2012;7(3):e33458. doi: 10.1371/journal.pone.0033458. Epub 2012 Mar 16.</citation>
    <PMID>22438934</PMID>
  </reference>
  <reference>
    <citation>Eden GF, Stein JF, Wood HM, Wood FB. Differences in eye movements and reading problems in dyslexic and normal children. Vision Res. 1994 May;34(10):1345-58. doi: 10.1016/0042-6989(94)90209-7.</citation>
    <PMID>8023443</PMID>
  </reference>
  <reference>
    <citation>Hutzler F, Wimmer H. Eye movements of dyslexic children when reading in a regular orthography. Brain Lang. 2004 Apr;89(1):235-42. doi: 10.1016/S0093-934X(03)00401-2.</citation>
    <PMID>15010255</PMID>
  </reference>
  <reference>
    <citation>Jainta S, Kapoula Z. Dyslexic children are confronted with unstable binocular fixation while reading. PLoS One. 2011 Apr 6;6(4):e18694. doi: 10.1371/journal.pone.0018694.</citation>
    <PMID>21494641</PMID>
  </reference>
  <reference>
    <citation>McConkie GW, Kerr PW, Reddix MD, Zola D. Eye movement control during reading: I. The location of initial eye fixations on words. Vision Res. 1988;28(10):1107-18. doi: 10.1016/0042-6989(88)90137-x.</citation>
    <PMID>3257013</PMID>
  </reference>
  <reference>
    <citation>McConkie GW, Kerr PW, Reddix MD, Zola D, Jacobs AM. Eye movement control during reading: II. Frequency of refixating a word. Percept Psychophys. 1989 Sep;46(3):245-53. doi: 10.3758/bf03208086.</citation>
    <PMID>2771616</PMID>
  </reference>
  <reference>
    <citation>Pavlidis GT. Eye movement differences between dyslexics, normal, and retarded readers while sequentially fixating digits. Am J Optom Physiol Opt. 1985 Dec;62(12):820-32. doi: 10.1097/00006324-198512000-00003.</citation>
    <PMID>4083326</PMID>
  </reference>
  <reference>
    <citation>Poynter HL, Schor C, Haynes HM, Hirsch J. Oculomotor functions in reading disability. Am J Optom Physiol Opt. 1982 Feb;59(2):116-27. doi: 10.1097/00006324-198202000-00002.</citation>
    <PMID>7065104</PMID>
  </reference>
  <reference>
    <citation>Prado C, Dubois M, Valdois S. The eye movements of dyslexic children during reading and visual search: impact of the visual attention span. Vision Res. 2007 Sep;47(19):2521-30. doi: 10.1016/j.visres.2007.06.001. Epub 2007 Aug 23.</citation>
    <PMID>17719073</PMID>
  </reference>
  <reference>
    <citation>Rounds BB, Manley CW, Norris RH. The effect of oculomotor training on reading efficiency. J Am Optom Assoc. 1991 Feb;62(2):92-9.</citation>
    <PMID>1814996</PMID>
  </reference>
  <reference>
    <citation>Shainberg MJ. Vision therapy and orthoptics. Am Orthopt J. 2010;60:28-32. doi: 10.3368/aoj.60.1.28.</citation>
    <PMID>21061881</PMID>
  </reference>
  <reference>
    <citation>Solan HA. Deficient eye-movement patterns in achieving high school students: three case histories. J Learn Disabil. 1985 Feb;18(2):66-70. doi: 10.1177/002221948501800201. No abstract available.</citation>
    <PMID>3973502</PMID>
  </reference>
  <reference>
    <citation>Solan HA. Eye movement problems in achieving readers: an update. Am J Optom Physiol Opt. 1985 Dec;62(12):812-9. doi: 10.1097/00006324-198512000-00002.</citation>
    <PMID>4083325</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Carly Lam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>reading eye movement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ocular Motility Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981875
org study id: HongKongPUVT
nct id: NCT02981875
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in number of fixation and regression during reading after 8 weeks of oculomotor training
time frame: 8 weeks
description: number of fixation and regression is measured by Visagraph per 100 words
measure: Change in reading rate during reading after 8 weeks of oculomotor training
time frame: 8 weeks
description: reading rate in number of words/min and fixation duration measured in seconds
measure: Change in perceptual span (words per fixation) during reading after 8 weeks of oculomotor training
time frame: 8 weeks
description: perceptual span measured in words per fixation
measure: Change in fixation duration (seconds) during reading after 8 weeks of oculomotor training
time frame: 8 weeks
description: fixation duration measured in seconds
measure: Change in symptom scores after 8 weeks of oculomotor training
time frame: 8 weeks
description: symptom scores is calculated with a scale of 0 to 4 for all the 8 items of manifested symptoms
arm group label: experimental
arm group type: Experimental
description: oculomotor training
arm group label: control
arm group type: Placebo Comparator
description: placebo vision training exercises
intervention type: Other
intervention name: oculomotor training
description: a sequence of vision training exercises which focused mainly in oculomotor skill
arm group label: experimental
intervention type: Other
intervention name: placebo
description: placebo vision training exercises involving minimal accommodation and vergence eye movement.
arm group label: control
criteria: 
gender: All
minimum age: 8 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carly SY Lam
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
citation: Bigelow ER, McKenzie BE. Unstable ocular dominance and reading ability. Perception. 1985;14(3):329-35. doi: 10.1068/p140329.
PMID: 4088794
citation: Biscaldi M, Gezeck S, Stuhr V. Poor saccadic control correlates with dyslexia. Neuropsychologia. 1998 Nov;36(11):1189-202. doi: 10.1016/s0028-3932(97)00170-x.
PMID: 9842764
citation: Borsting EJ, Rouse MW, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in children aged 9 to 18 years. Optom Vis Sci. 2003 Dec;80(12):832-8. doi: 10.1097/00006324-200312000-00014.
PMID: 14688547
citation: Bosse ML, Tainturier MJ, Valdois S. Developmental dyslexia: the visual attention span deficit hypothesis. Cognition. 2007 Aug;104(2):198-230. doi: 10.1016/j.cognition.2006.05.009. Epub 2006 Jul 21.
PMID: 16859667
citation: Bucci MP, Nassibi N, Gerard CL, Bui-Quoc E, Seassau M. Immaturity of the oculomotor saccade and vergence interaction in dyslexic children: evidence from a reading and visual search study. PLoS One. 2012;7(3):e33458. doi: 10.1371/journal.pone.0033458. Epub 2012 Mar 16.
PMID: 22438934
citation: Eden GF, Stein JF, Wood HM, Wood FB. Differences in eye movements and reading problems in dyslexic and normal children. Vision Res. 1994 May;34(10):1345-58. doi: 10.1016/0042-6989(94)90209-7.
PMID: 8023443
citation: Hutzler F, Wimmer H. Eye movements of dyslexic children when reading in a regular orthography. Brain Lang. 2004 Apr;89(1):235-42. doi: 10.1016/S0093-934X(03)00401-2.
PMID: 15010255
citation: Jainta S, Kapoula Z. Dyslexic children are confronted with unstable binocular fixation while reading. PLoS One. 2011 Apr 6;6(4):e18694. doi: 10.1371/journal.pone.0018694.
PMID: 21494641
citation: McConkie GW, Kerr PW, Reddix MD, Zola D. Eye movement control during reading: I. The location of initial eye fixations on words. Vision Res. 1988;28(10):1107-18. doi: 10.1016/0042-6989(88)90137-x.
PMID: 3257013
citation: McConkie GW, Kerr PW, Reddix MD, Zola D, Jacobs AM. Eye movement control during reading: II. Frequency of refixating a word. Percept Psychophys. 1989 Sep;46(3):245-53. doi: 10.3758/bf03208086.
PMID: 2771616
citation: Pavlidis GT. Eye movement differences between dyslexics, normal, and retarded readers while sequentially fixating digits. Am J Optom Physiol Opt. 1985 Dec;62(12):820-32. doi: 10.1097/00006324-198512000-00003.
PMID: 4083326
citation: Poynter HL, Schor C, Haynes HM, Hirsch J. Oculomotor functions in reading disability. Am J Optom Physiol Opt. 1982 Feb;59(2):116-27. doi: 10.1097/00006324-198202000-00002.
PMID: 7065104
citation: Prado C, Dubois M, Valdois S. The eye movements of dyslexic children during reading and visual search: impact of the visual attention span. Vision Res. 2007 Sep;47(19):2521-30. doi: 10.1016/j.visres.2007.06.001. Epub 2007 Aug 23.
PMID: 17719073
citation: Rounds BB, Manley CW, Norris RH. The effect of oculomotor training on reading efficiency. J Am Optom Assoc. 1991 Feb;62(2):92-9.
PMID: 1814996
citation: Shainberg MJ. Vision therapy and orthoptics. Am Orthopt J. 2010;60:28-32. doi: 10.3368/aoj.60.1.28.
PMID: 21061881
citation: Solan HA. Deficient eye-movement patterns in achieving high school students: three case histories. J Learn Disabil. 1985 Feb;18(2):66-70. doi: 10.1177/002221948501800201. No abstract available.
PMID: 3973502
citation: Solan HA. Eye movement problems in achieving readers: an update. Am J Optom Physiol Opt. 1985 Dec;62(12):812-9. doi: 10.1097/00006324-198512000-00002.
PMID: 4083325
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Carly Lam
investigator title: Professor
mesh term: Ocular Motility Disorders
sharing ipd: No