NCT07350330

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Oct 2025

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 Progress45%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
8 months 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

December 30, 2026

Last Updated

January 20, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 20, 2025

Last Update Submit

January 14, 2026

Conditions

Exotropia

Outcome Measures

Primary Outcomes (1)

  • Ocular alignment

    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 Outcomes (2)

  • palpebral fissure height

    from preoperative to 6 months postoperative

  • ocular incomitance

    from surgery till 6 months afterward

Study Arms (2)

Muscle transplantation

ACTIVE COMPARATOR

This group will undergo medial rectus resection, lateral rectus recession, with muscle transplantation

Procedure: muscle transplantation

Y splitting

ACTIVE COMPARATOR

This group will undergo medial rectus resection, lateral rectus recession, with Y splitting

Procedure: Y splitting

Interventions

muscle transplantationPROCEDURE

transplanting a resected part of medial rectus to the already recessed lateral rectus muscle

Muscle transplantation
Y splittingPROCEDURE

Y splitting of the recessed lateral rectus muscle

Y splitting

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Central Study Contacts

Alaa mohsen Elmaghraby, masters

CONTACT

+201115538151Alaa.Mohsen@med.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2025

First Posted

January 20, 2026

Study Start

October 30, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 20, 2026

Record last verified: 2025-12

Locations

EG(1)