The Effect of Oculo-Motor Exercises in Intermittent Exotropia

Intermittent Exotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661476
• Other study ID #: 10840098-604.01.01-E.34141
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: January 3, 2019

Study information

• Verified date: March 2019
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 3, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercises
• Exotropia
• Intermittent Exotropia

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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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. Rev — View 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.gaitp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prism cover test	Near and distant alternating prism cover test	6 weeks
Secondary	Streopsis test	Three-dimensional visual assessment	6 weeks
Secondary	Intermittent exotropia survery	Level of patient satisfaction	6 weeks
Secondary	Visual acuity	Snellen chart	6 weeks