NCT03661476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
Last Updated

December 17, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

September 5, 2018

Last Update Submit

December 14, 2019

Conditions

Intermittent ExotropiaExercises

Keywords

Intermittent ExotropiaOculo-Motor ExercisesPhysiotherapyIntermittent Exotropia Survey

Outcome Measures

Primary Outcomes (1)

  • Prism cover test

    Near and distant alternating prism cover test

    6 weeks

Secondary Outcomes (3)

  • Streopsis test

    6 weeks

  • Intermittent exotropia survery

    6 weeks

  • Visual acuity

    6 weeks

Study Arms (1)

Oculo-Motor Exercises (OME)

EXPERIMENTAL

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)

Interventions

Oculo-Motor Exercises (OME)BEHAVIORAL

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.

Oculo-Motor Exercises (OME)

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be between 2 and 17 years of age
  • Intermittent exotropia diagnosis
  • To have mental capacity in the level to understand and do exercises

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 15629828RESULT

  • 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.

    PMID: 25001323RESULT

  • 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.

    PMID: 21334899RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Candan Algun

    Faculty of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD PT

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 7, 2018

Study Start

August 13, 2018

Primary Completion

December 10, 2018

Study Completion

January 3, 2019

Last Updated

December 17, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)