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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

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.

02

Conditions studied

  • Intermittent Exotropia
  • Exercises

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Keywords

  • Intermittent Exotropia
  • Oculo-Motor Exercises
  • Physiotherapy
  • Intermittent Exotropia Survey
03

Who can participate

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

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
04

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.

05

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

06

Study locations

1 site
  • Istanbul Medipol University
    Istanbul, Beykoz 34810, Turkey
07

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

08

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 ↗

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