Strabismus, NoncomitantNCT05827393
Muscle Transplantation in Strabismus Surgery
A study testing muscle transplantation in people with Strabismus, Noncomitant, run by South Valley University at 1 site in Egypt.
Trial summary
All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Strabismus, Noncomitant
- What is being tested?
- muscle transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2021to May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with esotropia or exotropia of more than 60 prism dioptre
Who cannot join
- Muscular paralysis.
- High myopia. .Dissociated vertical divergence. .Accommodative esotropias.
- Large vertical deviations associated Alphabetic syndromes
- previous surgeries in either eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia
All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique
- Conditions
- Strabismus, Noncomitant
- Being tested
- muscle transplantation
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle transplantationProcedure or surgery
the resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | 15 patients with large angle esotropia Receives: Procedure: muscle transplantation |
| group B | Active comparator | 15 patients with large angle exotropia Receives: Procedure: muscle transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
the change of angle of strabismus will be assessed pre and post muscle transplantation procedure , the angle of strabismus will be measured pre operative and postoperative after one day using hirschburg test measured by degree
Measured: one day
Secondary outcomes (1)
assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
the stability of angle of strabismus will be assessed post muscle transplantation procedure , the angle of strabismus will be measured after six month post operative using hirschburg test measured by degree
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start11 Jul 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismus, NoncomitantStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa abody ahmed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827393
- Sponsor's protocol ID
- 155
- Status last verified
- Apr 2023
- First submitted
- 19 Feb 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Transplantation for Large Angle Horizontal Strabismus: Esotropia Versus Exotropia
- ClinicalTrials.gov ID
- NCT05827393
- Acronym / sponsor ID
- 155
- Conditions
- Strabismus, Noncomitant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
All the patients underwent standard muscle transplantation, where the resected extra stump of lateral or medial rectus muscle was transplanted to the medial or lateral rectus muscle using 6-0 prolene which wasrecessed by a standard recession technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: muscle transplantation15 patients with large angle esotropia |
| group B | Active comparator | Procedure: muscle transplantation15 patients with large angle exotropia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with esotropia or exotropia of more than 60 prism dioptre
Key exclusion criteria (4 listed)
- Muscular paralysis.
- High myopia. .Dissociated vertical divergence. .Accommodative esotropias.
- Large vertical deviations associated Alphabetic syndromes
- previous surgeries in either eye
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 |
|---|---|---|
| muscle transplantationthe resected extra stump of rectus muscle was transplanted to the other horizontal rectus muscle which was recessed by a standard recession technique | Procedure or surgery | group A, group B |
Primary outcome
Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
Time frame: one day
the change of angle of strabismus will be assessed pre and post muscle transplantation procedure , the angle of strabismus will be measured pre operative and postoperative after one day using hirschburg test measured by degree
1 secondary outcome
assess the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle transplantation in people with Strabismus, Noncomitant, run by South Valley 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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 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?
Results are not available in the source record.
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?
Compare the angle of strabismus after muscle transplantation procedure in large angle esotropia with large angle exotropia (time frame: one day). 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 25 Apr 2023.