StrabismusNCT04303832
Exercise Interventions of Eye Muscles Post Strabismus Surgery
A study testing eye exercises and eye glasses in people with Strabismus and Amblyopia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Strabismus, Amblyopia
- What is being tested?
- eye exercises and eye glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 26 Feb 2020
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Strabismus, Amblyopia
- Being tested
- eye exercises, eye glasses
- Keywords
- Strabismus and amplyobia and physiotherapy eye exercise
- Medical subject headings
- Strabismus, Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye exercisesOther
Eye exercises for correcting eye deviation
eye glassesDevice
Eye glasses for correcting eye deviation
| Study group | Role | What they receive |
|---|---|---|
| eye exercise group | Experimental | This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses Receives: Other: eye exercises; Device: eye glasses |
| control group | Sham comparator | This group had traditional treatment of strabismus which is eye glasses Receives: Device: eye glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in angle of deviation
deviation of the eye in direction rather than its normal position
Measured: pre and post 12 weeks
Secondary outcomes (1)
change in visual acuity
measure the ability of the eye to see the objects
Measured: pre and post 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Oct 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
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
- None (open label)
- 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, M.Sc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303832
- Sponsor's protocol ID
- P.T.REC/012/001903
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: information about statistical analysis and study report will be sheared with other researcher later on
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Interventions of Eye Muscles Post Strabismus Surgery
- ClinicalTrials.gov ID
- NCT04303832
- Acronym / sponsor ID
- P.T.REC/012/001903
- Conditions
- Strabismus, Amblyopia
- Keywords
- Strabismus and amplyobia and physiotherapy eye exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 11 Mar 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eye exercise group | Experimental | Other: eye exercises, Device: eye glassesThis group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses |
| control group | Sham comparator | Device: eye glassesThis group had traditional treatment of strabismus which is eye glasses |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| eye exercisesEye exercises for correcting eye deviation | Other | eye exercise group |
| eye glassesEye glasses for correcting eye deviation | Device | control group, eye exercise group |
Primary outcome
change in angle of deviation
Time frame: pre and post 12 weeks
deviation of the eye in direction rather than its normal position
1 secondary outcome
change in visual acuity
Time frame: pre and post 12 weeks
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 11 Mar 2020.
- Individual participant dataSharing planned: Yes. information about statistical analysis and study report will be sheared with other researcher later on
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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, M.Sc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye exercises and eye glasses in people with Strabismus and Amblyopia, 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 5 inclusion and 4 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 11 Mar 2020. 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. Some participants in this study may receive a placebo. 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?
change in angle of deviation (time frame: pre and post 12 weeks). 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 11 Mar 2020.