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The Effect of Oculo-Motor Exercises in Intermittent Exotropia

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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

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE August 13, 2018
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Prism cover test [ Time Frame: 6 weeks ]
Near and distant alternating prism cover test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
  • Streopsis test [ Time Frame: 6 weeks ]
    Three-dimensional visual assessment
  • Intermittent exotropia survery [ Time Frame: 6 weeks ]
    Level of patient satisfaction
  • Visual acuity [ Time Frame: 6 weeks ]
    Snellen chart
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Oculo-Motor Exercises in Intermittent Exotropia
Official Title  ICMJE Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intermittent Exotropia
  • Exercises
Intervention  ICMJE 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.

Study Arms  ICMJE 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.
Intervention: Behavioral: Oculo-Motor Exercises (OME)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2019)
51
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
50
Actual Study Completion Date  ICMJE January 3, 2019
Actual Primary Completion Date December 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03661476
Other Study ID Numbers  ICMJE 10840098-604.01.01-E.34141
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gülay Aras, Medipol University
Study Sponsor  ICMJE Medipol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Candan Algun Faculty of Health Sciences
PRS Account Medipol University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP