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

Primary Purpose

Exotropia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
surgery
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exotropia

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type. Exclusion Criteria: Angle of deviation less than 40 PD or more than 55 PD. History of previous surgery. Inconcomitant exotropia. Incomitance in any gaze. Associated vertical deviation(oblique dysfunction,A or V pattern). Patients with neurological deficit.

Sites / Locations

  • Reham fawzy elsherbiny

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group 1 :Two muscle surgery

group 2:Three muscle surgery

Arm Description

30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)

39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)

Outcomes

Primary Outcome Measures

alignment in the primary position
measuring any misalignment by prism bar
palpebral fissure height
measuring with millimeter
End gaze deficit
measuring with prism bar

Secondary Outcome Measures

Full Information

First Posted
December 26, 2020
Last Updated
December 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05643456
Brief Title
Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles
Acronym
XT
Official Title
Comparison Between The Results Of Operating Two Muscles And Operating Three Muscles For The Treatment Of Large Angle Exotropia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exotropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group will do two muscles surgery; bilateral lateral rectus recession. The 2nd group will do three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1 :Two muscle surgery
Arm Type
Active Comparator
Arm Description
30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)
Arm Title
group 2:Three muscle surgery
Arm Type
Active Comparator
Arm Description
39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
alignment in the primary position
Description
measuring any misalignment by prism bar
Time Frame
1 week to 6 months
Title
palpebral fissure height
Description
measuring with millimeter
Time Frame
1 week to 6 months
Title
End gaze deficit
Description
measuring with prism bar
Time Frame
1 week to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type. Exclusion Criteria: Angle of deviation less than 40 PD or more than 55 PD. History of previous surgery. Inconcomitant exotropia. Incomitance in any gaze. Associated vertical deviation(oblique dysfunction,A or V pattern). Patients with neurological deficit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lobna MH Khazbm, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reham fawzy elsherbiny
City
Giza
ZIP/Postal Code
0000
Country
Egypt

12. IPD Sharing Statement

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Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles

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