The Effect of Oculo-Motor Exercises in Intermittent Exotropia

December 14, 2019 updated by: Gülay Aras, Medipol University

Investigation of the Effect of Oculo-Motor Exercises in Intermittent Exotropic Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34810
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prism cover test
Time Frame: 6 weeks
Near and distant alternating prism cover test
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streopsis test
Time Frame: 6 weeks
Three-dimensional visual assessment
6 weeks
Intermittent exotropia survery
Time Frame: 6 weeks
Level of patient satisfaction
6 weeks
Visual acuity
Time Frame: 6 weeks
Snellen chart
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Investigators

  • Study Director: Candan Algun, Faculty of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2018

Primary Completion (Actual)

December 10, 2018

Study Completion (Actual)

January 3, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-604.01.01-E.34141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intermittent Exotropia

Clinical Trials on Oculo-Motor Exercises (OME)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe