Bilateral and Unilateral Horizontal Strabismus Surgery

June 15, 2021 updated by: Mohamed Farag Khalil Ibrahiem, Minia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
      • Minya, Egypt, 61111
        • Mohamed F K Ibrahiem
    • Minia
      • Minya, Minia, Egypt, 61111
        • Faculty of Medicine

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

4 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • more than 3 years old.
  • alternating esotropia or exotropia

Exclusion Criteria:

  • unilateral strabismus
  • paralytic or restrictive strabismus

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
Time Frame: one and half year
This result was measured by simultaneous prism cover test and expressed in prism diopter
one and half year

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Principal Investigator: Sahar TA Abdelaziz, MD, assistant professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 21, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minia University Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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