The Effect of Oculo-Motor Exercises in Intermittent Exotropia
Primary Purpose
Intermittent Exotropia, Exercises
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oculo-Motor Exercises (OME)
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Exotropia focused on measuring Intermittent Exotropia, Oculo-Motor Exercises, Physiotherapy, Intermittent Exotropia Survey
Eligibility 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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oculo-Motor Exercises (OME)
Arm Description
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.
Outcomes
Primary Outcome Measures
Prism cover test
Near and distant alternating prism cover test
Secondary Outcome Measures
Streopsis test
Three-dimensional visual assessment
Intermittent exotropia survery
Level of patient satisfaction
Visual acuity
Snellen chart
Full Information
NCT ID
NCT03661476
First Posted
September 5, 2018
Last Updated
December 14, 2019
Sponsor
Medipol University
1. Study Identification
Unique Protocol Identification Number
NCT03661476
Brief Title
The Effect of Oculo-Motor Exercises in Intermittent Exotropia
Official Title
Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
January 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia, Exercises
Keywords
Intermittent Exotropia, Oculo-Motor Exercises, Physiotherapy, Intermittent Exotropia Survey
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oculo-Motor Exercises (OME)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Oculo-Motor Exercises (OME)
Intervention Description
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 Measure Information:
Title
Prism cover test
Description
Near and distant alternating prism cover test
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Streopsis test
Description
Three-dimensional visual assessment
Time Frame
6 weeks
Title
Intermittent exotropia survery
Description
Level of patient satisfaction
Time Frame
6 weeks
Title
Visual acuity
Description
Snellen chart
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candan Algun
Organizational Affiliation
Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15629828
Citation
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.
Results Reference
result
PubMed Identifier
25001323
Citation
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.
Results Reference
result
PubMed Identifier
21334899
Citation
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.
Results Reference
result
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The Effect of Oculo-Motor Exercises in Intermittent Exotropia
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