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Ocular Motility DisordersNCT02981875

Oculomotor Training Improves Reading Eye Movement

A study testing oculomotor training in people with Ocular Motility Disorders, run by The Hong Kong Polytechnic University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Ocular Motility Disorders
What is being tested?
oculomotor training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

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

About this study

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.

Read the 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.

Being tested
oculomotor training, placebo
Keywords
reading eye movement
Medical subject headings
Ocular Motility Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oculomotor trainingOther

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

  • placeboOther

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

Study groups in NCT02981875
Study groupRoleWhat they receive
experimentalExperimentaloculomotor training
Receives: Other: oculomotor training
controlPlacebo comparatorplacebo vision training exercises
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 weeks

Secondary outcomes (4)

  1. 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

    Measured: 8 weeks

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

    perceptual span measured in words per fixation

    Measured: 8 weeks

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

    fixation duration measured in seconds

    Measured: 8 weeks

  4. 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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion30 Sep 2016
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02981875
Sponsor's protocol ID
HongKongPUVT
Status last verified
Aug 2020
First submitted
17 Aug 2016
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

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

    PubMed 4088794

  • 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.

    PubMed 9842764

  • 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.

    PubMed 14688547

  • 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.

    PubMed 16859667

  • 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.

    PubMed 22438934

  • 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.

    PubMed 8023443

  • 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.

    PubMed 15010255

  • 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.

    PubMed 21494641

  • 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.

    PubMed 3257013

  • 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.

    PubMed 2771616

  • 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.

    PubMed 4083326

  • 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.

    PubMed 7065104

  • 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.

    PubMed 17719073

  • Rounds BB, Manley CW, Norris RH. The effect of oculomotor training on reading efficiency. J Am Optom Assoc. 1991 Feb;62(2):92-9.

    PubMed 1814996

  • Shainberg MJ. Vision therapy and orthoptics. Am Orthopt J. 2010;60:28-32. doi: 10.3368/aoj.60.1.28.

    PubMed 21061881

Questions about this trial

What is this clinical trial studying?

A study testing oculomotor training in people with Ocular Motility Disorders, run by The Hong Kong Polytechnic University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in number of fixation and regression during reading after 8 weeks of oculomotor training (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981875, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.

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