Back to resultsComparing Adjustable Sutures Surgery
Primary Purpose
Strabismus, Comitant
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Adjustable strabismus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus, Comitant
Eligibility Criteria
Inclusion Criteria:
- More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients
Exclusion Criteria:
- Patients with previous strabismus surgery Patients with oblique deviations
Sites / Locations
- Faculty of Medicine- Minia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early adjustable suture surgery
Late adjustable suture surgery
Arm Description
Suture adjustment after 2 hours of surgery
Suture adjustment after 24 hours of surgery
Outcomes
Primary Outcome Measures
Alignment of the strabismus
Percentage of patients with successful postoperative alignment using prism cover test for measurement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04617158
Brief Title
Comparing Adjustable Sutures Surgery
Official Title
Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
April 10, 2022 (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
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment
Detailed Description
Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus, Comitant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early adjustable suture surgery
Arm Type
Active Comparator
Arm Description
Suture adjustment after 2 hours of surgery
Arm Title
Late adjustable suture surgery
Arm Type
Active Comparator
Arm Description
Suture adjustment after 24 hours of surgery
Intervention Type
Procedure
Intervention Name(s)
Adjustable strabismus surgery
Intervention Description
Adjustable surgery will be done using sliding nose technique using fornix approach
Primary Outcome Measure Information:
Title
Alignment of the strabismus
Description
Percentage of patients with successful postoperative alignment using prism cover test for measurement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients
Exclusion Criteria:
Patients with previous strabismus surgery Patients with oblique deviations
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- Minia University
City
Minya
ZIP/Postal Code
61111
Country
Egypt
12. IPD Sharing Statement
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Comparing Adjustable Sutures Surgery
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