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Cicatricial Upper Eyelid Entropion Management

Primary Purpose

Entropion

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suture-less surgical procedure
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Entropion

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 5, 2022
Last Updated
October 19, 2023
Sponsor
Minia University
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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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