NCT02981875

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Status
completed

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 Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

August 17, 2016

Last Update Submit

August 2, 2020

Conditions

Keywords

reading eye movement

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Secondary Outcomes (4)

  • Change in reading rate during reading after 8 weeks of oculomotor training

    8 weeks

  • Change in perceptual span (words per fixation) during reading after 8 weeks of oculomotor training

    8 weeks

  • Change in fixation duration (seconds) during reading after 8 weeks of oculomotor training

    8 weeks

  • Change in symptom scores after 8 weeks of oculomotor training

    8 weeks

Study Arms (2)

experimental

EXPERIMENTAL

oculomotor training

Other: oculomotor training

control

PLACEBO COMPARATOR

placebo vision training exercises

Other: placebo

Interventions

a sequence of vision training exercises which focused mainly in oculomotor skill

experimental
placeboOTHER

placebo vision training exercises involving minimal accommodation and vergence eye movement.

control

Eligibility Criteria

Age8 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • Bigelow ER, McKenzie BE. Unstable ocular dominance and reading ability. Perception. 1985;14(3):329-35. doi: 10.1068/p140329.

    PMID: 4088794BACKGROUND
  • 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: 9842764BACKGROUND
  • 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: 14688547BACKGROUND
  • 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: 16859667BACKGROUND
  • 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: 22438934BACKGROUND
  • 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: 8023443BACKGROUND
  • 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: 15010255BACKGROUND
  • 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: 21494641BACKGROUND
  • 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: 3257013BACKGROUND
  • 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: 2771616BACKGROUND
  • 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: 4083326BACKGROUND
  • 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: 7065104BACKGROUND
  • 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: 17719073BACKGROUND
  • 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: 1814996BACKGROUND
  • Shainberg MJ. Vision therapy and orthoptics. Am Orthopt J. 2010;60:28-32. doi: 10.3368/aoj.60.1.28.

    PMID: 21061881BACKGROUND
  • 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: 3973502BACKGROUND
  • 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: 4083325BACKGROUND

MeSH Terms

Conditions

Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Carly SY Lam

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2016

First Posted

December 5, 2016

Study Start

January 1, 2015

Primary Completion

September 30, 2016

Study Completion

September 30, 2019

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share