Strabismus, DivergentNCT07373197
Lateral Rectus Muscle Strangulation in Cases of Exotropia
A study testing Muscle strangulation in people with Strabismus, Divergent, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of our study to evaluate effect of lateral rectus muscle strangulation as a novel effective weakening technique in cases of exotropia. It is a case-series intervensional study with a total 12 participant who are diagnosed as exophoria or intermittent exotropia who are older than 4 years old. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Strabismus, Divergent
- What is being tested?
- Muscle strangulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 2 Feb 2025
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- intermittent exotropia
Who cannot join
- previous squint surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Rectus Muscle Strangulation: A New Weakening Technique in Cases of Exotropia
The goal of our study to evaluate effect of lateral rectus muscle strangulation as a novel effective weakening technique in cases of exotropia.
It is a case-series intervensional study with a total 12 participant who are diagnosed as exophoria or intermittent exotropia who are older than 4 years old.
All patients will be assessed regarding their angle of deviation and then undergo lateral rectus muscle strangulation under general anesthesia and then will be followed- up at 1st day, 1st week, 1st month and 6th months.
Read the detailed description
Under general anesthesia and after sterilization and draping of the eyes, an eye speculum is inserted. The muscle is exposed and hooked through either a fornix-based or limbal-based incision. Careful dissection is carried out to delineate the muscle edge, a previously measured blook of the lateral rectus muscle is sutured (strangulated) with proline 10/0 as in (fig-1). Patients will be followed-up next day after surgery then after 1 month and after 6 months.
- Conditions
- Strabismus, Divergent
- Being tested
- Muscle strangulation
- Keywords
- Exotropia, Lateral rectus muscle
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle strangulationProcedure or surgery
lateral rectus muscle strangulation as a weakening technique in cases of exotropia.
| Study group | Role | What they receive |
|---|---|---|
| lateral rectus muscle strangulation | Experimental | lateral rectus muscle strangulation as a weakening technique in cases of exotropia. Receives: Procedure: Muscle strangulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of strabismus
the correction was done by lateral rectus muscle strangulation
Measured: 12 months
Secondary outcomes (1)
orthophoria
to make both eyes aligned together, and to maintain orthophoria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Jul 2024
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Strabismus, DivergentStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mounir, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373197
- Sponsor's protocol ID
- Soh-Med-24-09-12PD
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we havenot decided until now to share IPD with other researchers
Publications
Rageh MA, Awadein A, Arfeen SA. Extraocular muscle fenestration: a novel weakening procedure. Can J Ophthalmol. 2020 Oct;55(5):455-457. doi: 10.1016/j.jcjo.2020.05.018. Epub 2020 Aug 26. No abstract available.
PubMed 32860744Taher SG, Rageh MA, Hashem O. Extra Ocular Muscle Fenestration as a Weakening Maneuver for Surgical Management of Strabismus: A Randomized Pilot Clinical Trial. Clin Ophthalmol. 2022 Jan 8;16:63-70. doi: 10.2147/OPTH.S347092. eCollection 2022.
PubMed 35035214Koc F, Ozal H, Yasar H, Firat E. Resolution in partially accomodative esotropia during occlusion treatment for amblyopia. Eye (Lond). 2006 Mar;20(3):325-8. doi: 10.1038/sj.eye.6701874.
PubMed 15933753
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Rectus Muscle Strangulation: A New Weakening Technique in Cases of Exotropia
- ClinicalTrials.gov ID
- NCT07373197
- Acronym / sponsor ID
- Soh-Med-24-09-12PD
- Conditions
- Strabismus, Divergent
- Keywords
- Exotropia, Lateral rectus muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 28 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.
The goal of our study to evaluate effect of lateral rectus muscle strangulation as a novel effective weakening technique in cases of exotropia.
It is a case-series intervensional study with a total 12 participant who are diagnosed as exophoria or intermittent exotropia who are older than 4 years old.
All patients will be assessed regarding their angle of deviation and then undergo lateral rectus muscle strangulation under general anesthesia and then will be followed- up at 1st day, 1st week, 1st month and 6th months.
Detailed description
Under general anesthesia and after sterilization and draping of the eyes, an eye speculum is inserted. The muscle is exposed and hooked through either a fornix-based or limbal-based incision. Careful dissection is carried out to delineate the muscle edge, a previously measured blook of the lateral rectus muscle is sutured (strangulated) with proline 10/0 as in (fig-1). Patients will be followed-up next day after surgery then after 1 month and after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lateral rectus muscle strangulation | Experimental | Procedure: Muscle strangulationlateral rectus muscle strangulation as a weakening technique in cases of exotropia. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- intermittent exotropia
Key exclusion criteria (1 listed)
- previous squint surgery
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 strangulationlateral rectus muscle strangulation as a weakening technique in cases of exotropia. | Procedure or surgery | lateral rectus muscle strangulation |
Primary outcome
Correction of strabismus
Time frame: 12 months
the correction was done by lateral rectus muscle strangulation
1 secondary outcome
orthophoria
Time frame: 12 months
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 28 Jan 2026.
- Background: PubMed 32860744Rageh MA, Awadein A, Arfeen SA. Extraocular muscle fenestration: a novel weakening procedure. Can J Ophthalmol. 2020 Oct;55(5):455-457. doi: 10.1016/j.jcjo.2020.05.018. Epub 2020 Aug 26. No abstract available.
- Background: PubMed 35035214Taher SG, Rageh MA, Hashem O. Extra Ocular Muscle Fenestration as a Weakening Maneuver for Surgical Management of Strabismus: A Randomized Pilot Clinical Trial. Clin Ophthalmol. 2022 Jan 8;16:63-70. doi: 10.2147/OPTH.S347092. eCollection 2022.
- Background: PubMed 15933753Koc F, Ozal H, Yasar H, Firat E. Resolution in partially accomodative esotropia during occlusion treatment for amblyopia. Eye (Lond). 2006 Mar;20(3):325-8. doi: 10.1038/sj.eye.6701874.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. we havenot decided until now to share IPD with other researchers
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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.
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 strangulation in people with Strabismus, Divergent, run by Sohag 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: finished, as of the sponsor's last update on 28 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?
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?
Correction of strabismus (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07373197, which also lists 3 linked publications.
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 28 Jan 2026.