NCT07784842

Brief Summary

This a randomized clinical trial comparing True muscle transplantation surgery versus Augmented Semi hang back recession for treatment of large angle exotropia

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Mar 2026Jan 2027

Study Start

First participant enrolled

March 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

exotropia,strabismus,muscle transplantation,augmented recession

Outcome Measures

Primary Outcomes (1)

  • Surgical success rate at 6 months

    Proportion of patients with ocular alignment within 10 prism diopters of orthotropia measured by prism and alternate cover test

    6 months post-surgery

Study Arms (2)

True Muscle Transplantation Surgery

EXPERIMENTAL

Patients in this group will undergo True Muscle Transplantation Surgery For treatment of large angle exotropia

Procedure: True Muscle Transplantation Surgery

Augmented Semi hang back Recession

EXPERIMENTAL

Patients in this group will undergo Augmented Semi hang back Recession for treatment of large angle exotropia

Procedure: Augmented Semi hang back Recession

Interventions

true Muscle Transplantation surgery for treatment of large angle Exotropia

True Muscle Transplantation Surgery

Augmented Semi hang back Recession for treatment of large angle Exotropia

Augmented Semi hang back Recession

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with large angle exotropia more than 50 prism diopters.
  • No previous squint surgery.

You may not qualify if:

  • Patients with severe ocular surface diseases as ocular cicatricial pemphigoid and severe dry eye.
  • Severe systemic illness that prevents general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minya University Hospital - Ophthalmology Department

Minya, Minya Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Central Study Contacts

Hassnaa Mohamed Abdelhameed, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly assigned to 1 of 2 surgical intervention arms
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Ophthalmology, Minia University

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 25, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations