Back to resultsManagement of Consecutive Exotropia
Primary Purpose
Strabismus, Concomitant Squint, Divergent Strabismus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Strabismus surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Strabismus
Eligibility Criteria
Inclusion Criteria:
- Patients with consecutive exotropia.
- Eight years old or more.
- Cooperative patients.
Exclusion Criteria:
- Adduction deficit.
- Mental disability.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medial rectus advancement with resection
Medial rectus advancement with lateral rectus recession
Arm Description
Surgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus
Surgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time
Outcomes
Primary Outcome Measures
Percentage of patients with satisfactory postoperative alignment
Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961021
Brief Title
Management of Consecutive Exotropia
Official Title
Management of Consecutive Exotropia and Its Effect on Ocular Motility
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia 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
Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Concomitant Squint, Divergent Strabismus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medial rectus advancement with resection
Arm Type
Active Comparator
Arm Description
Surgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus
Arm Title
Medial rectus advancement with lateral rectus recession
Arm Type
Active Comparator
Arm Description
Surgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time
Intervention Type
Procedure
Intervention Name(s)
Strabismus surgery
Intervention Description
Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle
Primary Outcome Measure Information:
Title
Percentage of patients with satisfactory postoperative alignment
Description
Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with consecutive exotropia.
Eight years old or more.
Cooperative patients.
Exclusion Criteria:
Adduction deficit.
Mental disability.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar TA Abdelaziz, MD
Organizational Affiliation
Faculty of Medicine, Minia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Management of Consecutive Exotropia
We'll reach out to this number within 24 hrs