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CompletedNCT03661476Updated Dec 17, 2019

The Effect of Oculo-Motor Exercises in Intermittent Exotropia

An interventional study of Oculo-Motor Exercises (OME) in Intermittent Exotropia and Exercises, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
2 Years to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Motor Activity by Medipol University — 7 open to participants now, 8 under way, none of them phase 3. Motor Activity · Medipol University.

Enrollment
7th of 18
51 · median 47
Started
2018
the only one that year
No phase
18 of 18
7 open now
Registered
1st of 18
by date

Among the 18 studies in Motor Activity by Medipol University, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 18 with no phase, and was the 1st registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

7 of the 18 studies in Motor Activity by Medipol University are open now, in 1 country. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 2 Years to 17 Years · all sexes · healthy volunteers too.

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02

Study summary

In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and convergence failure in the first decade of life. This situation adversely affects children's psychosocial development and creates worries about personal relationships and work life in their future lives. Patients' hesitant attitudes towards surgical treatment led to the out-of-surgery techniques such as exercise therapy. No studies have been found in the literature on the efficancy of the intermittent exotropia treatments with oculo-motor exercises. In our study, it was aimed to investigate the effects of oculo-motor exercises on intermittent exotropia in children.

Read the detailed description

50 volunteer school-aged children between 2-17 years of age) were included in our study. Oculo-motor home exercise protocols were given to all participants for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. Participants were assessed cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis test and patient satisfaction levels by intermittent exotropia survery.

03

Conditions studied

  • Intermittent Exotropia
  • Exercises

Browse trials for

Keywords

  • Intermittent Exotropia
  • Oculo-Motor Exercises
  • Physiotherapy
  • Intermittent Exotropia Survey
04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be between 2 and 17 years of age
  • Intermittent exotropia diagnosis
  • To have mental capacity in the level to understand and do exercises

Exclusion criteria

Exclusion Criteria:

  • Not complying with age criteria
  • Constant exotropia
  • Having undergone eye surgery
  • Those with systemic disease that prevent exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Oculo-Motor Exercises (OME)

    10 repetitive four different oculomotor exercise protocols with eye stabilization were organized as home programs for 6 weeks, twice a day in the morning and evening each day of the week.

    Behavioral: Oculo-Motor Exercises (OME)

Interventions

  • BehavioralOculo-Motor Exercises (OME)

    Oculomotor Exercises (OME); The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still. The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still. The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus. The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes.

06

What researchers measure

Primary outcomes

  1. Prism cover test

    Near and distant alternating prism cover test

    Time frame: 6 weeks

Secondary outcomes

  1. Streopsis test

    Three-dimensional visual assessment

    Time frame: 6 weeks

  2. Intermittent exotropia survery

    Level of patient satisfaction

    Time frame: 6 weeks

  3. Visual acuity

    Snellen chart

    Time frame: 6 weeks

07

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Beykoz 34810, Turkey
08

References and documents

Publications

  • Govindan M, Mohney BG, Diehl NN, Burke JP. Incidence and types of childhood exotropia: a population-based study. Ophthalmology. 2005 Jan;112(1):104-8. doi: 10.1016/j.ophtha.2004.07.033. PubMed 15629828 ↗
  • Joyce KE, Beyer F, Thomson RG, Clarke MP. A systematic review of the effectiveness of treatments in altering the natural history of intermittent exotropia. Br J Ophthalmol. 2015 Apr;99(4):440-50. doi: 10.1136/bjophthalmol-2013-304627. Epub 2014 Jul 7. PubMed 25001323 ↗
  • Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19. PubMed 21334899 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Dec 2018, 3 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 3 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2018
First posted
Sep 7, 2018
StartActual
Aug 13, 2018
Primary completionActual
Dec 10, 2018
CompletionActual
Jan 3, 2019
Last update
Dec 17, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03661476
Lead sponsor
Medipol University
Responsible party
Gülay Aras (PhD PT, Medipol University) — Principal investigator
First posted
Sep 7, 2018
Start date
Aug 13, 2018
Primary completion
Dec 10, 2018
Completion
Jan 3, 2019
Last update
Dec 17, 2019

Study contacts

Candan Algun
study director · Faculty of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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