Back to resultsModified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Primary Purpose
Entropion
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified anterior Lamellar Recession
Sponsored by
About this trial
This is an interventional treatment trial for Entropion
Eligibility Criteria
Inclusion Criteria: All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes. Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included Exclusion Criteria: Patients with a follow-up period of fewer than 12 months. Patients with very severe UCE and required posterior lamellar grafts. Patients with etiology other than trachoma. Patients with dysplastic lashes without entropion were excluded
Sites / Locations
- Ehab tharwat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified anterior Lamellar Recession
Arm Description
All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes.
Outcomes
Primary Outcome Measures
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Success rate
The cases will be considered succeed if there is no recurrence of the entropion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854420
Brief Title
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Official Title
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar 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
This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion
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
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified anterior Lamellar Recession
Arm Type
Experimental
Arm Description
All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes.
Intervention Type
Procedure
Intervention Name(s)
Modified anterior Lamellar Recession
Intervention Description
ALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise.
Primary Outcome Measure Information:
Title
Success rate
Description
The cases will be considered succeed if there is no recurrence of the entropion
Time Frame
3 months post operative
Title
Success rate
Description
The cases will be considered succeed if there is no recurrence of the entropion
Time Frame
6 months post operative
Title
Success rate
Description
The cases will be considered succeed if there is no recurrence of the entropion
Time Frame
9 months post operative
Title
Success rate
Description
The cases will be considered succeed if there is no recurrence of the entropion
Time Frame
12 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included
Exclusion Criteria:
Patients with a follow-up period of fewer than 12 months.
Patients with very severe UCE and required posterior lamellar grafts.
Patients with etiology other than trachoma.
Patients with dysplastic lashes without entropion were excluded
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
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