Back to resultsCicatricial Upper Eyelid Entropion Management
Primary Purpose
Entropion
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suture-less surgical procedure
Sponsored by
About this trial
This is an interventional treatment trial for Entropion
Eligibility Criteria
Inclusion Criteria:
- Upper eyelid cicatricial entropion with no history of previous surgery.
- Cooperative patients older then 16 years old.
Exclusion Criteria:
- Previous lid surgery.
- Senile and mechanical entropion.
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Suture-less entropion technique
Arm Description
suture-less technique for cicatricial entropion
Outcomes
Primary Outcome Measures
Eyelid margin reposition to the normal position
posterior edge of eyelid opposed to eye globe using slit lamp examination of the inner margin of the upper lid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371626
Brief Title
Cicatricial Upper Eyelid Entropion Management
Official Title
Suture-less Procedure for Management of Cicatricial Upper Eyelid Entropion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (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
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion to detect its long-term efficacy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Entropion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suture-less entropion technique
Arm Type
Other
Arm Description
suture-less technique for cicatricial entropion
Intervention Type
Procedure
Intervention Name(s)
Suture-less surgical procedure
Intervention Description
Suture-less technique will be used in treatment for cicatricial upper eyelid entropion
Primary Outcome Measure Information:
Title
Eyelid margin reposition to the normal position
Description
posterior edge of eyelid opposed to eye globe using slit lamp examination of the inner margin of the upper lid
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Upper eyelid cicatricial entropion with no history of previous surgery.
Cooperative patients older then 16 years old.
Exclusion Criteria:
Previous lid surgery.
Senile and mechanical entropion.
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
Plan to Share IPD
Undecided
Learn more about this trial
Cicatricial Upper Eyelid Entropion Management
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