Comparative Study of Muscle Transplantation Versus Y Splitting Recession Technique in Treatment of Large Angle Exotropia

January 14, 2026 updated by: Ain Shams University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain shams university
        • Contact:

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:

  • Age should be of more than 6 years Exotropia of an angle ranging from 50 to 70 PD Myopic or hypermetropic refraction

Exclusion Criteria:

  • history of previous squint surgery significant vertical deviation incomitant squint in the form of paralytic or restrictive disorder any neurological disease

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
Active Comparator: Muscle transplantation
This group will undergo medial rectus resection, lateral rectus recession, with muscle transplantation
Procedure: muscle transplantation
transplanting a resected part of medial rectus to the already recessed lateral rectus muscle
Active Comparator: Y splitting
This group will undergo medial rectus resection, lateral rectus recession, with Y splitting
Procedure: Y splitting
Y splitting of the recessed lateral rectus muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the operation till six months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
palpebral fissure height
Time Frame: from preoperative to 6 months postoperative
Assess whether this is a change in palpebral fissure height pre- and postoperatively by measurement using a ruler
from preoperative to 6 months postoperative
ocular incomitance
Time Frame: from surgery till 6 months afterward
The presence of ocular incomitance and gaze restriction using prisms and motility tests after surgery
from surgery till 6 months afterward

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

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)

October 30, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD223/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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