Exercise Interventions for Improving Eye Control Post Strabismus Surgery

NCT05303779 | Completed DMC

• 1 other identifier: P.T.REC/012/003505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

• 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).

  before the treatment and after 12 weeks (at the end of the treatment period )

Study Arms (2)

experimental group

EXPERIMENTAL

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

Other: Exercise Interventions of Eye Muscles; Drug: Medication and eye glasses

control group

ACTIVE COMPARATOR

control group will receive medication and eye glasses post strabismus surgery

Drug: Medication and eye glasses

Interventions

Exercise Interventions of Eye Muscles OTHER

Application of eye exercise for improving eye control post strabismus surgery

Also known as: experimental

experimental group

Medication and eye glasses DRUG

medication and eye glasses used post strabismus surgery

Also known as: control

control group; experimental group

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Strabismus

Interventions

Dosage Forms; Eyeglasses

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Amany Abdel Wahid, PhD

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 31, 2022
• Study Start: March 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: August 15, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)