Back to resultsBasic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
Primary Purpose
Strabismus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Strabismus surgery
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus
Eligibility Criteria
Inclusion Criteria:
- Basic type intermittent exotropia
Exclusion Criteria:
- previous strabismus surgery restrictive strabismus
Sites / Locations
- Faculty of medicine - Minia University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Basic intermittent exotropia patients
Arm Description
Outcomes
Primary Outcome Measures
Risk factors for postoperative overcorrections and under corrections
as axial length of the globe, age, sex and refractive error
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03153423
Brief Title
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
Official Title
Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 5, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
January 14, 2020 (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
5. Study Description
Brief Summary
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Basic intermittent exotropia patients
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Strabismus surgery
Intervention Description
Recession and resection of horizontal extra ocular muscles
Primary Outcome Measure Information:
Title
Risk factors for postoperative overcorrections and under corrections
Description
as axial length of the globe, age, sex and refractive error
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Basic type intermittent exotropia
Exclusion Criteria:
previous strabismus surgery restrictive strabismus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed F Ibrahiem, MD
Organizational Affiliation
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
Learn more about this trial
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
We'll reach out to this number within 24 hrs