Exotropia Equal or More Than 50 Prism DiopterNCT07143032
A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia
A study testing Extropia squint surgery in people with Exotropia Equal or More Than 50 Prism Diopter, run by Sohag University.
Trial summary
This is a randomized comparative interventional study that aims to compare the surgical outcomes of correcting large angle exotropia (≥50 prism diopter) by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial… Read more about this study
- Who is it for?
- Ages 3 to 50 years
- Conditions the study is for
- Exotropia Equal or More Than 50 Prism Diopter
- What is being tested?
- Extropia squint surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2027
- 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 3 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with large-angle exotropia (≥50 prism diopter).
Who cannot join
- Patients with an exodeviation angle of less than 50 prism diopter.
- History of previous strabismus surgery.
- Restrictive or paretic strabismus or history of botulinum toxin injections for strabismus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Alahmady Hamad Alsaman, Professor contact
About this study
Official title: A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia: Bilateral Lateral Rectus Recession With Medial Rectus Resection, Bilateral Medial Rectus Resection and Resection-Transplantation
This is a randomized comparative interventional study that aims to compare the surgical outcomes of correcting large angle exotropia (≥50 prism diopter) by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation,
Read the detailed description
This is a randomized comparative interventional study that will be conducted on patients with large angle exotropia before and after doing surgical correction using three different surgical techniques including : 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.
- Being tested
- Extropia squint surgery
- Keywords
- exotropia, Recession, Resection, Transplantation
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extropia squint surgeryProcedure or surgery
patients with large angle exotropia will be treated by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.
| Study group | Role | What they receive |
|---|---|---|
| bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection | Active comparator | patients with large angle exotropia treated by bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection Receives: Procedure: Extropia squint surgery |
| bilateral medial rectus muscle resection | Active comparator | patients with large angle exotropia treated by bilateral medial rectus muscle resection Receives: Procedure: Extropia squint surgery |
| unilateral medial rectus muscle resection with lateral rectus muscle transplantation | Active comparator | patients with large angle exotropia treated by unilateral medial rectus muscle resection with lateral rectus muscle transplantation Receives: Procedure: Extropia squint surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in ocular alignment
Detect ocular alignment by using Krimsky test to measure angle of deviation in prism diopter
Measured: at one month, 6 month and one year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
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 Exotropia Equal or More Than 50 Prism DiopterStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Abdelraheem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143032
- Sponsor's protocol ID
- Soh-Med-25-7-4MD
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cifuentes DL, Pineles SL, Demer JL, Velez FG. Surgical success and lateral incomitance following three-muscle surgery for large-angle horizontal strabismus. J AAPOS. 2018 Feb;22(1):17-21. doi: 10.1016/j.jaapos.2017.10.005. Epub 2017 Dec 1.
PubMed 29199031Talebnejad MR, Johari MK, Khalili MR, Zare M. Supramaximal Recession and Resection Surgery in Large-Angle Strabismus: Outcomes of Large Interventional Case Series Exotropia and Esotropia. J Curr Ophthalmol. 2020 Mar 23;32(1):82-87. doi: 10.4103/JOCO.JOCO_22_20. eCollection 2020 Jan-Mar.
PubMed 32510018Peters ER, Archer SM. Long-standing, large-angle exotropia in adults. Am Orthopt J. 2007;57:104-6. doi: 10.3368/aoj.57.1.104.
PubMed 21149163
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Three Surgical Techniques in Large Angle Exotropia: Bilateral Lateral Rectus Recession With Medial Rectus Resection, Bilateral Medial Rectus Resection and Resection-Transplantation
- ClinicalTrials.gov ID
- NCT07143032
- Acronym / sponsor ID
- Soh-Med-25-7-4MD
- Keywords
- exotropia, Recession, Resection, Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Aug 2025 (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 is a randomized comparative interventional study that aims to compare the surgical outcomes of correcting large angle exotropia (≥50 prism diopter) by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation,
Detailed description
This is a randomized comparative interventional study that will be conducted on patients with large angle exotropia before and after doing surgical correction using three different surgical techniques including : 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection | Active comparator | Procedure: Extropia squint surgerypatients with large angle exotropia treated by bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection |
| bilateral medial rectus muscle resection | Active comparator | Procedure: Extropia squint surgerypatients with large angle exotropia treated by bilateral medial rectus muscle resection |
| unilateral medial rectus muscle resection with lateral rectus muscle transplantation | Active comparator | Procedure: Extropia squint surgerypatients with large angle exotropia treated by unilateral medial rectus muscle resection with lateral rectus muscle transplantation |
Who may qualify
- Ages
- 3 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with large-angle exotropia (≥50 prism diopter).
Key exclusion criteria (3 listed)
- Patients with an exodeviation angle of less than 50 prism diopter.
- History of previous strabismus surgery.
- Restrictive or paretic strabismus or history of botulinum toxin injections for strabismus.
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 |
|---|---|---|
| Extropia squint surgerypatients with large angle exotropia will be treated by three different surgical techniques including: 1/ bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection 2/bilateral medial rectus muscle resection, 3/unilateral medial rectus muscle resection with lateral rectus muscle transplantation ,to compare the surgical outcomes between them. | Procedure or surgery | bilateral lateral rectus muscle recession with unilateral medial rectus muscle resection, bilateral medial rectus muscle resection, unilateral medial rectus muscle resection with lateral rectus muscle transplantation |
Primary outcome
changes in ocular alignment
Time frame: at one month, 6 month and one year postoperatively.
Detect ocular alignment by using Krimsky test to measure angle of deviation in prism diopter
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 27 Aug 2025.
- Background: PubMed 29199031Cifuentes DL, Pineles SL, Demer JL, Velez FG. Surgical success and lateral incomitance following three-muscle surgery for large-angle horizontal strabismus. J AAPOS. 2018 Feb;22(1):17-21. doi: 10.1016/j.jaapos.2017.10.005. Epub 2017 Dec 1.
- Background: PubMed 32510018Talebnejad MR, Johari MK, Khalili MR, Zare M. Supramaximal Recession and Resection Surgery in Large-Angle Strabismus: Outcomes of Large Interventional Case Series Exotropia and Esotropia. J Curr Ophthalmol. 2020 Mar 23;32(1):82-87. doi: 10.4103/JOCO.JOCO_22_20. eCollection 2020 Jan-Mar.
- Background: PubMed 21149163Peters ER, Archer SM. Long-standing, large-angle exotropia in adults. Am Orthopt J. 2007;57:104-6. doi: 10.3368/aoj.57.1.104.
- Individual participant dataSharing planned: Undecided
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.
Alahmady Hamad Alsaman, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Extropia squint surgery in people with Exotropia Equal or More Than 50 Prism Diopter, run by Sohag University.
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 3 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: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 sara ahmed abdelraheem, Assistant lecturer (+201153987387, sara011096@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in ocular alignment (time frame: at one month, 6 month and one year postoperatively.). 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 NCT07143032, 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 27 Aug 2025.