Exercise Interventions of Eye Muscles Post Strabismus Surgery

March 7, 2020 updated by: Amany Refaat Mohamed Abdel Wahid, Cairo University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

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

  • Egypt
      • Cairo, Egypt
        • Cairo 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

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in angle of deviation
Time Frame: pre and post 12 weeks
deviation of the eye in direction rather than its normal position
pre and post 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in visual acuity
Time Frame: pre and post 12 weeks
measure the ability of the eye to see the objects
pre and post 12 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

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

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)

October 1, 2018

Primary Completion (Actual)

February 26, 2020

Study Completion (Actual)

February 26, 2020

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 7, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/001903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

information about statistical analysis and study report will be sheared with other researcher later on

IPD Sharing Time Frame

later on

IPD Sharing Access Criteria

for physical therapist and ophthalmologist

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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.

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