Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles (XT)

December 7, 2022 updated by: reham fawzy elsherbiny, Cairo University

Comparison Between The Results Of Operating Two Muscles And Operating Three Muscles For The Treatment Of Large Angle Exotropia

Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).

Study Type

Interventional

Enrollment (Actual)

69

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
      • Giza, Egypt, 0000
        • Reham fawzy elsherbiny

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.

Exclusion Criteria:

  1. Angle of deviation less than 40 PD or more than 55 PD.
  2. History of previous surgery.
  3. Inconcomitant exotropia.
  4. Incomitance in any gaze.
  5. Associated vertical deviation(oblique dysfunction,A or V pattern).
  6. Patients with neurological deficit.

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: group 1 :Two muscle surgery
30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)
Procedure: surgery

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.

The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.
Active Comparator: group 2:Three muscle surgery
39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)
Procedure: surgery

69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.

The 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
alignment in the primary position
Time Frame: 1 week to 6 months
measuring any misalignment by prism bar
1 week to 6 months
palpebral fissure height
Time Frame: 1 week to 6 months
measuring with millimeter
1 week to 6 months
End gaze deficit
Time Frame: 1 week to 6 months
measuring with prism bar
1 week to 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Lobna MH Khazbm, MD, Cairo 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)

July 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

December 26, 2020

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Estimate)

December 8, 2022

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIO

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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