Back to resultsExercise Interventions of Eye Muscles Post Strabismus Surgery
Primary Purpose
Strabismus, Amblyopia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
eye exercises
eye glasses
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus focused on measuring Strabismus and amplyobia and physiotherapy eye exercise
Eligibility Criteria
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
eye exercise group
control group
Arm Description
This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses
This group had traditional treatment of strabismus which is eye glasses
Outcomes
Primary Outcome Measures
change in angle of deviation
deviation of the eye in direction rather than its normal position
Secondary Outcome Measures
change in visual acuity
measure the ability of the eye to see the objects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04303832
Brief Title
Exercise Interventions of Eye Muscles Post Strabismus Surgery
Official Title
Exercise Interventions of Eye Muscles Post Strabismus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Amblyopia
Keywords
Strabismus and amplyobia and physiotherapy eye exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eye exercise group
Arm Type
Experimental
Arm Description
This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
This group had traditional treatment of strabismus which is eye glasses
Intervention Type
Other
Intervention Name(s)
eye exercises
Intervention Description
Eye exercises for correcting eye deviation
Intervention Type
Device
Intervention Name(s)
eye glasses
Intervention Description
Eye glasses for correcting eye deviation
Primary Outcome Measure Information:
Title
change in angle of deviation
Description
deviation of the eye in direction rather than its normal position
Time Frame
pre and post 12 weeks
Secondary Outcome Measure Information:
Title
change in visual acuity
Description
measure the ability of the eye to see the objects
Time Frame
pre and post 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany Abdel Wahid, M.Sc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Exercise Interventions of Eye Muscles Post Strabismus Surgery
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