The Effect of Oculo-Motor Exercises in Intermittent Exotropia

Sponsor

Medipol University (Other)

Overall Status

Completed

CT.gov ID

NCT03661476

Collaborator

(none)

Enrollment

Location

Arm

4.7

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Exotropia Exercises	Behavioral: Oculo-Motor Exercises (OME)	N/A

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 Design

Study Type:

Interventional

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 :

Aug 13, 2018

Actual Primary Completion Date :

Dec 10, 2018

Actual Study Completion Date :

Jan 3, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Prism cover test [6 weeks]
Near and distant alternating prism cover test

Secondary Outcome Measures

Streopsis test [6 weeks]
Three-dimensional visual assessment
Intermittent exotropia survery [6 weeks]
Level of patient satisfaction
Visual acuity [6 weeks]
Snellen chart

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University	Istanbul	Beykoz	Turkey	34810

Sponsors and Collaborators

Medipol University

Investigators

Study Director: Candan Algun, Faculty of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gülay Aras, PhD PT, Medipol University

ClinicalTrials.gov Identifier:

NCT03661476

Other Study ID Numbers:

10840098-604.01.01-E.34141

First Posted:

Sep 7, 2018

Last Update Posted:

Dec 17, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gülay Aras, PhD PT, Medipol University

Intermittent Exotropia

Oculo-Motor Exercises

Physiotherapy

Intermittent Exotropia Survey

Additional relevant MeSH terms:

Exotropia

Study Results

No Results Posted as of Dec 17, 2019