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
About this trial
This is an interventional treatment trial for Exotropia
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.
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
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
Learn more about this trial
Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles
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