Back to resultsBilateral and Unilateral Horizontal Strabismus Surgery
Primary Purpose
Strabismus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
symmetrical and asymmetrical horizontal strabismus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus
Eligibility Criteria
Inclusion Criteria:
- more than 3 years old.
- alternating esotropia or exotropia
Exclusion Criteria:
- unilateral strabismus
- paralytic or restrictive strabismus
Sites / Locations
- Faculty of Medicine
- Mohamed F K Ibrahiem
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Asymmetrical surgery
Symmetrical
Arm Description
This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery
This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia
Outcomes
Primary Outcome Measures
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
This result was measured by simultaneous prism cover test and expressed in prism diopter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04199286
Brief Title
Bilateral and Unilateral Horizontal Strabismus Surgery
Official Title
Assessment of Symmetrical and Asymmetrical Horizontal Strabismus Surgery: Efficacy and Lateral Incomitance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
June 14, 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
No
5. Study Description
Brief Summary
This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asymmetrical surgery
Arm Type
Active Comparator
Arm Description
This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery
Arm Title
Symmetrical
Arm Type
Active Comparator
Arm Description
This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia
Intervention Type
Procedure
Intervention Name(s)
symmetrical and asymmetrical horizontal strabismus surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
Description
This result was measured by simultaneous prism cover test and expressed in prism diopter
Time Frame
one and half year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
more than 3 years old.
alternating esotropia or exotropia
Exclusion Criteria:
unilateral strabismus
paralytic or restrictive strabismus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar TA Abdelaziz, MD
Organizational Affiliation
Assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Minya
State/Province
Minia
ZIP/Postal Code
61111
Country
Egypt
Facility Name
Mohamed F K Ibrahiem
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34471346
Citation
Ismail AA, Abdelkader MF, Mohamed AA, Abdelaziz ST. Evaluation of Efficacy and Lateral Gaze Incomitance in Symmetrical and Asymmetrical Surgery for Concomitant Esotropia and Exotropia. Clin Ophthalmol. 2021 Aug 26;15:3613-3621. doi: 10.2147/OPTH.S326659. eCollection 2021.
Results Reference
derived
Learn more about this trial
Bilateral and Unilateral Horizontal Strabismus Surgery
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