StrabismusNCT05303779
Exercise Interventions for Improving Eye Control Post Strabismus Surgery
A study testing Exercise Interventions of Eye Muscles and Medication and eye glasses in people with Strabismus, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Exercise Interventions of Eye Muscles and Medication and eye glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Interventions of Eye Muscles for Improving Eye Control Post Strabismus Surgery
The purpose of this study will be focused on the following issue:
- 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?
Read the 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.
- Conditions
- Strabismus
- Being tested
- Exercise Interventions of Eye Muscles, Medication and eye glasses
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Interventions of Eye MusclesOther
Also called experimental
Application of eye exercise for improving eye control post strabismus surgery
Medication and eye glassesDrug
Also called control
medication and eye glasses used post strabismus surgery
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | experimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery Receives: 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 Receives: Drug: Medication and eye glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before the treatment and after 12 weeks (at the end of the treatment period )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Mar 2022
- Primary completion15 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Refaat Mohamed Abdel Wahid, Cairo University
- Investigators
- Amany Abdel Wahid, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303779
- Sponsor's protocol ID
- P.T.REC/012/003505
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Interventions of Eye Muscles for Improving Eye Control Post Strabismus Surgery
- ClinicalTrials.gov ID
- NCT05303779
- Acronym / sponsor ID
- P.T.REC/012/003505
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be focused on the following issue:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Exercise Interventions of Eye Muscles, Drug: Medication and eye glassesexperimental group will receive eye exercises in addition to medication and eye glasses post strabismus surgery |
| control group | Active comparator | Drug: Medication and eye glassescontrol group will receive medication and eye glasses post strabismus surgery |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Interventions of Eye MusclesAlso: experimentalApplication of eye exercise for improving eye control post strabismus surgery | Other | experimental group |
| Medication and eye glassesAlso: controlmedication and eye glasses used post strabismus surgery | Drug | control group, experimental group |
Primary outcome
changing in eye control
Time frame: before the treatment and after 12 weeks (at the end of the treatment period )
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amany Abdel Wahid, PhD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Interventions of Eye Muscles and Medication and eye glasses in people with Strabismus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changing in eye control (time frame: before the treatment and after 12 weeks (at the end of the treatment period )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.