Exercise Interventions of Eye Muscles Post Strabismus Surgery

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04303832

Collaborator

(none)

Enrollment

Location

Arms

16.9

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It will be hypothesized that:

Eye exercises have a positive effect on correction of remaining ocular deviation post strabismus surgery.
Eye exercises have a positive effect on improving amplyobia.

Condition or Disease	Intervention/Treatment	Phase
Strabismus Amblyopia	Other: eye exercises Device: eye glasses	N/A

Detailed Description

This study applied to determine the effect of physiotherapy exercises on correction the remaining ocular deviation which still present following the strabismus surgery and also its effect on amplyobia.

Different type of physiotherapy exercises was applied to experimental group for 12 weeks beside the medical treatment applied post-surgery while the control group received traditional treatment only.

The near and far angles of ocular deviation were measured before and after the treatment for evaluation of strabismus and measuring visual acuity for evaluation of amplyobia.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise Interventions of Eye Muscles Post Strabismus Surgery

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Feb 26, 2020

Actual Study Completion Date :

Feb 26, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eye exercise group This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses	Other: eye exercises Eye exercises for correcting eye deviation Device: eye glasses Eye glasses for correcting eye deviation
Sham Comparator: control group This group had traditional treatment of strabismus which is eye glasses	Device: eye glasses Eye glasses for correcting eye deviation

Arm

Intervention/Treatment

Experimental: eye exercise group

This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses

Other: eye exercises

Eye exercises for correcting eye deviation

Device: eye glasses

Eye glasses for correcting eye deviation

Sham Comparator: control group

This group had traditional treatment of strabismus which is eye glasses

Device: eye glasses

Eye glasses for correcting eye deviation

Outcome Measures

Primary Outcome Measures

change in angle of deviation [pre and post 12 weeks]
deviation of the eye in direction rather than its normal position

Secondary Outcome Measures

change in visual acuity [pre and post 12 weeks]
measure the ability of the eye to see the objects

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients received strabismus operation
All types of strabismus surgery will be included
They selected from Outpatient Clinic
Patients begin the training program after 2 weeks of operation or more than this
The patient still suffering from amblyopia post strabismus surgery

Exclusion Criteria:

Muscular disorders that will impair performance during training.
Neurological disorders.
Malignant conditions.
Psychiatric illness, severe behavior or cognitive disorders. Children who can't understand the therapist's instructions and orders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Amany Abdel Wahid, M.Sc, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amany Refaat Mohamed Abdel Wahid, assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT04303832

Other Study ID Numbers:

P.T.REC/012/001903

First Posted:

Mar 11, 2020

Last Update Posted:

Mar 11, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Keywords provided by Amany Refaat Mohamed Abdel Wahid, assistant lecturer, Cairo University

Strabismus and amplyobia and physiotherapy eye exercise

Additional relevant MeSH terms:

Amblyopia

Strabismus

Study Results

No Results Posted as of Mar 11, 2020