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The Effect of Oculo-Motor Exercises in Intermittent Exotropia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661476
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gülay Aras, Medipol University

Brief 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.

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Exercises Behavioral: Oculo-Motor Exercises (OME) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : January 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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.





Primary Outcome Measures :
  1. Prism cover test [ Time Frame: 6 weeks ]
    Near and distant alternating prism cover test


Secondary Outcome Measures :
  1. Streopsis test [ Time Frame: 6 weeks ]
    Three-dimensional visual assessment

  2. Intermittent exotropia survery [ Time Frame: 6 weeks ]
    Level of patient satisfaction

  3. Visual acuity [ Time Frame: 6 weeks ]
    Snellen chart



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661476


Locations
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Turkey
Istanbul Medipol University
Istanbul, Beykoz, Turkey, 34810
Sponsors and Collaborators
Medipol University
Investigators
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Study Director: Candan Algun Faculty of Health Sciences
Publications of Results:
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Responsible Party: Gülay Aras, PhD PT, Medipol University
ClinicalTrials.gov Identifier: NCT03661476    
Other Study ID Numbers: 10840098-604.01.01-E.34141
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülay Aras, Medipol University:
Intermittent Exotropia
Oculo-Motor Exercises
Physiotherapy
Intermittent Exotropia Survey
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases