Back to resultsLees Screen in Concomitant Strabismus
Primary Purpose
Strabismus
Status
Recruiting
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:
- Concomitant esotropia
- Concomitant exotropia
- Above 10 years old patients
Exclusion Criteria:
- Restrictive and paralytic strabismus
- Previous strabismus surgery
- Mental disability
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Concomitant strabismus patients
Arm Description
Horizontal strabismus surgery
Outcomes
Primary Outcome Measures
postoperative Lees screen
detect any restriction in muscle field
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04213053
Brief Title
Lees Screen in Concomitant Strabismus
Official Title
Changes in Range of Ocular Motility Following Horizontal Rectus Muscle Surgery in Concomitant Strabismus; a Quantitate Measurements Using Lees Screen
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
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
Preoperative and postoperative Lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle
Detailed Description
Preoperative and postoperative Lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
detect if there are any change in motility after concomitant horizontal muscle surgery
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concomitant strabismus patients
Arm Type
Other
Arm Description
Horizontal strabismus surgery
Intervention Type
Procedure
Intervention Name(s)
strabismus surgery
Intervention Description
Lees screen before and after concomitant strabismus surgery
Primary Outcome Measure Information:
Title
postoperative Lees screen
Description
detect any restriction in muscle field
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Concomitant esotropia
Concomitant exotropia
Above 10 years old patients
Exclusion Criteria:
Restrictive and paralytic strabismus
Previous strabismus surgery
Mental disability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed F Ibrahiem, MD
Phone
00201064311860
Email
mohamedfka@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar T Abelaziz, MD
Phone
00201065716074
Email
sahar.torky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar TA Abdelaziz, MD
Organizational Affiliation
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed FK Ibrahiem, MD
Phone
00201064311860
Email
mohamedfka@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Lees Screen in Concomitant Strabismus
We'll reach out to this number within 24 hrs