- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07784842
True Muscle Transplantation Surgery Versus Augmented Semi Hang Back Recession in Large Angle Exotropia: Evaluation of Efficacy and Lateral Gaze Incomitance
August 20, 2026 updated by: Hassnaa Mohamed Abdelhameed Ahmed
This a randomized clinical trial comparing True muscle transplantation surgery versus Augmented Semi hang back recession for treatment of large angle exotropia
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
large angle exotropia is a challenging to treat surgically .40
patients will be randomized into 2 groups and followed for 6 months to assess alignment and success rate
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hassnaa Mohamed Abdelhameed, Assistant lecturer
- Phone Number: +201158861290
- Email: hasnaa.abdelhamid@mu.edu.eg
Study Locations
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypt, 61111
- Recruiting
- Minya University Hospital - Ophthalmology Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with large angle exotropia more than 50 prism diopters.
- No previous squint surgery.
Exclusion Criteria:
- Patients with severe ocular surface diseases as ocular cicatricial pemphigoid and severe dry eye.
- Severe systemic illness that prevents general anesthesia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: True Muscle Transplantation Surgery
Patients in this group will undergo True Muscle Transplantation Surgery For treatment of large angle exotropia
|
true Muscle Transplantation surgery for treatment of large angle Exotropia
|
|
Experimental: Augmented Semi hang back Recession
Patients in this group will undergo Augmented Semi hang back Recession for treatment of large angle exotropia
|
Augmented Semi hang back Recession for treatment of large angle Exotropia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical success rate at 6 months
Time Frame: 6 months post-surgery
|
Proportion of patients with ocular alignment within 10 prism diopters of orthotropia measured by prism and alternate cover test
|
6 months post-surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
August 20, 2026
First Submitted That Met QC Criteria
August 20, 2026
First Posted (Actual)
August 25, 2026
Study Record Updates
Last Update Posted (Actual)
August 25, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MiniaU-Oph- 2026-EXOT-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.