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Exercise Interventions for Improving Eye Control Post Strabismus Surgery

Primary Purpose

Strabismus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercise Interventions of Eye Muscles
Medication and eye glasses
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Criteria of selecting the patients include the following:
  • Patients are both males and females.
  • Their age will range from (5-15) years.
  • Patients received strabismus operation.
  • They will be selected from Outpatient Clinic of Research Institute of Ophthalmology.
  • Patients will begin the training program after 2 weeks of operation.
  • All types of strabismus surgery will be included.

Exclusion Criteria:

The subjects will be excluded from the study if they meet one of the following criteria;

  • Muscular disorders that will impair performance during training.
  • Any organic lesion in the eye.
  • 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

Active Comparator

Arm Label

experimental group

control group

Arm Description

experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery

control group will receive medication and eye glasses post strabismus surgery

Outcomes

Primary Outcome Measures

changing in eye control
The level of control will be evaluated in each patient at both distance and near fixation using Intermittent Exotropia Control Scale. Fixation targets will be at 3 meters for distance fixation and it will be at 33 centimeters for near fixation. Intermittent Exotropia Control Scale 5 = Constant exotropia 4 = Exotropia > 50% of the exam before dissociation 3 = Exotropia < 50% of the exam before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria) The scale ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control).

Secondary Outcome Measures

Full Information

First Posted
February 26, 2022
Last Updated
February 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05303779
Brief Title
Exercise Interventions for Improving Eye Control Post Strabismus Surgery
Official Title
Exercise Interventions of Eye Muscles for Improving Eye Control Post Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study will be focused on the following issue: 1. The aim of this study is to determine therapeutic effect of postoperative eye exercises on improving eye control after the strabismus surgery. HYPOTHESES: It will be hypothesized that: • Eye exercises have a positive effect on improving eye control post strabismus surgery. RESEARCH QUESTION:" • Do postoperative eye exercises improve eye control post strabismus surgery?
Detailed Description
Therapeutic procedures: Patient will be informed about measurement and treatment procedure before beginning of the treatment. Patient will be asked to follow physician instructions. Patients will be asked to avoid participation in any rehabilitation program prior to the study which may affect the result of the study. Measurement procedures will be applied for each patient. They will start the treatment program after 2 weeks of the surgery. The subjects will be divided into two groups (experimental group and control group) with equal numbers of patients in each group: Control group Participants within the control group will receive traditional care and medication following strabismus surgery. Experimental group Participants within the experimental group will receive physiotherapy exercises beside traditional care and medication after strabismus surgery. Physical therapy exercises will apply in the office and home. Office exercises will involve palming exercise, pencil push-ups, brock string exercise, thumb exercise (Near-distance jump), balance board exercise, Proprioceptors Neuromuscular Facilitating (PNF) exercise, occlusive therapy, eye hand coordination and computer therapy. Office exercises will be done two sessions per week for three months. Each session will be about 1 hour. Exercises will also perform at home from the first session including eye exercises in all directions, pencil push-ups, thumb exercise (Near-distance jump),brock string exercise, and dominant eye occlusion for 1 hour daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery
Arm Title
control group
Arm Type
Active Comparator
Arm Description
control group will receive medication and eye glasses post strabismus surgery
Intervention Type
Other
Intervention Name(s)
Exercise Interventions of Eye Muscles
Other Intervention Name(s)
experimental
Intervention Description
Application of eye exercise for improving eye control post strabismus surgery
Intervention Type
Drug
Intervention Name(s)
Medication and eye glasses
Other Intervention Name(s)
control
Intervention Description
medication and eye glasses used post strabismus surgery
Primary Outcome Measure Information:
Title
changing in eye control
Description
The level of control will be evaluated in each patient at both distance and near fixation using Intermittent Exotropia Control Scale. Fixation targets will be at 3 meters for distance fixation and it will be at 33 centimeters for near fixation. Intermittent Exotropia Control Scale 5 = Constant exotropia 4 = Exotropia > 50% of the exam before dissociation 3 = Exotropia < 50% of the exam before dissociation 2 = No exotropia unless dissociated, recovers in > 5 seconds 1 = No exotropia unless dissociated, recovers in 1-5 seconds 0 = No exotropia unless dissociated, recovers in < 1 second (phoria) The scale ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control).
Time Frame
before the treatment and after 12 weeks (at the end of the treatment period )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Criteria of selecting the patients include the following: Patients are both males and females. Their age will range from (5-15) years. Patients received strabismus operation. They will be selected from Outpatient Clinic of Research Institute of Ophthalmology. Patients will begin the training program after 2 weeks of operation. All types of strabismus surgery will be included. Exclusion Criteria: The subjects will be excluded from the study if they meet one of the following criteria; Muscular disorders that will impair performance during training. Any organic lesion in the eye. 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, PhD
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise Interventions for Improving Eye Control Post Strabismus Surgery

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