ExotropiaNCT07350330
Comparative Study of Muscle Transplantation Versus Y Splitting Recession Technique in Treatment of Large Angle Exotropia
A study testing muscle transplantation and Y splitting in people with Exotropia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study is designed to correct large-angle exotropia by monocular surgery. It compares two augmented recession techniques, which are recession with muscle transplantation and recession with Y splitting. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Exotropia
- What is being tested?
- muscle transplantation and Y splitting
- 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
- 30 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age should be of more than 6 years Exotropia of an angle ranging from 50 to 70 PD Myopic or hypermetropic refraction
Who cannot join
- history of previous squint surgery significant vertical deviation incomitant squint in the form of paralytic or restrictive disorder any neurological disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo
Alaa Mohsen Elmaghraby, masters, +201115538151, Alaa.Mohsen@med.asu.edu.eg
About this study
This study is designed to correct large-angle exotropia by monocular surgery. It compares two augmented recession techniques, which are recession with muscle transplantation and recession with Y splitting.
- Conditions
- Exotropia
- Being tested
- muscle transplantation, Y splitting
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle transplantationProcedure or surgery
transplanting a resected part of medial rectus to the already recessed lateral rectus muscle
Y splittingProcedure or surgery
Y splitting of the recessed lateral rectus muscle
| Study group | Role | What they receive |
|---|---|---|
| Muscle transplantation | Active comparator | This group will undergo medial rectus resection, lateral rectus recession, with muscle transplantation Receives: Procedure: muscle transplantation |
| Y splitting | Active comparator | This group will undergo medial rectus resection, lateral rectus recession, with Y splitting Receives: Procedure: Y splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular alignment
To measure ocular alignment using prisms after lateral rectus recession with muscle transplantation versus lateral rectus recession with Y splitting
Measured: from the operation till six months postoperatively
Secondary outcomes (2)
palpebral fissure height
Assess whether this is a change in palpebral fissure height pre- and postoperatively by measurement using a ruler
Measured: from preoperative to 6 months postoperative
ocular incomitance
The presence of ocular incomitance and gaze restriction using prisms and motility tests after surgery
Measured: from surgery till 6 months afterward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExotropiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350330
- Sponsor's protocol ID
- FMASU MD223/2025
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Muscle Transplantation Versus Y Splitting Recession Technique in Treatment of Large Angle Exotropia
- ClinicalTrials.gov ID
- NCT07350330
- Acronym / sponsor ID
- FMASU MD223/2025
- Conditions
- Exotropia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (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.
This study is designed to correct large-angle exotropia by monocular surgery. It compares two augmented recession techniques, which are recession with muscle transplantation and recession with Y splitting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle transplantation | Active comparator | Procedure: muscle transplantationThis group will undergo medial rectus resection, lateral rectus recession, with muscle transplantation |
| Y splitting | Active comparator | Procedure: Y splittingThis group will undergo medial rectus resection, lateral rectus recession, with Y splitting |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age should be of more than 6 years Exotropia of an angle ranging from 50 to 70 PD Myopic or hypermetropic refraction
Key exclusion criteria (1 listed)
- history of previous squint surgery significant vertical deviation incomitant squint in the form of paralytic or restrictive disorder any neurological disease
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 transplantationtransplanting a resected part of medial rectus to the already recessed lateral rectus muscle | Procedure or surgery | Muscle transplantation |
| Y splittingY splitting of the recessed lateral rectus muscle | Procedure or surgery | Y splitting |
Primary outcome
Ocular alignment
Time frame: from the operation till six months postoperatively
To measure ocular alignment using prisms after lateral rectus recession with muscle transplantation versus lateral rectus recession with Y splitting
2 secondary outcomes
palpebral fissure height
Time frame: from preoperative to 6 months postoperative
ocular incomitance
Time frame: from surgery till 6 months afterward
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and Y splitting in people with Exotropia, run by Ain Shams 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 1 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: looking for participants now, as of the sponsor's last update on 20 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa mohsen Elmaghraby, masters (+201115538151, Alaa.Mohsen@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular alignment (time frame: from the operation till six months postoperatively). 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 20 Jan 2026.