The Effect of Oculo-Motor Exercises in Intermittent Exotropia

• ClinicalTrials.gov Identifier: NCT03661476
• Recruitment Status: Completed
• First Posted: September 7, 2018
• Last Update Posted: December 17, 2019
• Sponsor: Medipol University
• Information provided by (Responsible Party): Gülay Aras, Medipol University

Tracking Information

• First Submitted Date: September 5, 2018
• First Posted Date: September 7, 2018
• Last Update Posted Date: December 17, 2019
• Actual Study Start Date: August 13, 2018
• Actual Primary Completion Date: December 10, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2018)

Prism cover test [ Time Frame: 6 weeks ]

Near and distant alternating prism cover test

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Intermittent Exotropia
• Exercises

Intervention

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

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 *

• 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.
• 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. Review.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2019): 51
• Original Estimated Enrollment (submitted: September 5, 2018): 50
• Actual Study Completion Date: January 3, 2019
• Actual Primary Completion Date: December 10, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT03661476
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Gülay Aras, Medipol University
• Study Sponsor: Medipol University
• Collaborators: Not Provided

Investigators

• Study Director: Candan Algun; Faculty of Health Sciences

• PRS Account: Medipol University
• Verification Date: March 2019