Bilateral and Unilateral Horizontal Strabismus Surgery

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04199286

Collaborator

(none)

Enrollment

Locations

Arms

17.8

Actual Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery

Condition or Disease	Intervention/Treatment	Phase
Strabismus	Procedure: symmetrical and asymmetrical horizontal strabismus surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessment of Symmetrical and Asymmetrical Horizontal Strabismus Surgery: Efficacy and Lateral Incomitance

Actual Study Start Date :

Dec 21, 2019

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Jun 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Asymmetrical surgery This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery	Procedure: symmetrical and asymmetrical horizontal strabismus surgery surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye
Active Comparator: Symmetrical This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia	Procedure: symmetrical and asymmetrical horizontal strabismus surgery surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye

Arm

Intervention/Treatment

Active Comparator: Asymmetrical surgery

This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery

Procedure: symmetrical and asymmetrical horizontal strabismus surgery

surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye

Active Comparator: Symmetrical

This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia

Procedure: symmetrical and asymmetrical horizontal strabismus surgery

surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye

Outcome Measures

Primary Outcome Measures

There was 95% success rate in asymmetrical group compared with 90% in symmetrical one [one and half year]
This result was measured by simultaneous prism cover test and expressed in prism diopter

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 28 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

more than 3 years old.
alternating esotropia or exotropia

Exclusion Criteria:

unilateral strabismus
paralytic or restrictive strabismus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Minya	Minia	Egypt	61111
2	Mohamed F K Ibrahiem	Minya		Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

Principal Investigator: Sahar TA Abdelaziz, MD, Assistant professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Farag Khalil Ibrahiem, Assistant Professor, Minia University

ClinicalTrials.gov Identifier:

NCT04199286

Other Study ID Numbers:

Minia University Hospital

First Posted:

Dec 13, 2019

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Study Results

No Results Posted as of Jun 18, 2021