Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion

May 10, 2023 updated by: Ehab Tharwat, Al-Azhar University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • New Damietta
      • Damieta, New Damietta, Egypt, 34517
        • Ehab tharwat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified anterior Lamellar Recession
All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes.
Procedure: Modified anterior Lamellar Recession
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 3 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
3 months post operative
Success rate
Time Frame: 6 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
6 months post operative
Success rate
Time Frame: 9 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
9 months post operative
Success rate
Time Frame: 12 months post operative
The cases will be considered succeed if there is no recurrence of the entropion
12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Modified ALR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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