Anterior Lamellar Recession vs Bilamellar Tarsal Rotation in Upper Lid Cicatricial Trichiasis

November 23, 2022 updated by: Ehab Tharwat, Al-Azhar University
in recent years there has been a significant shift from this destructive procedure to a reconstructive procedure such as Anterior Lamellar Recession (ALR) and Bilamellar Tarsal Rotation (BLTR).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

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

48 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with upper lid cicatricial trichiasis that requires surgical intervention

Exclusion Criteria:

  • Refusal of the patients.
  • Associated entropion., 3) Severe ocular surface disease.
  • Previous eyelid surgery.
  • Associated lid laxity.
  • Lack of adequate follow-up

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior Lamellar Recession
Procedure: Anterior Lamellar Recession
ALR is a common surgical treatment that splits the skin and orbicularis oculi muscle from the tarsus and conjunctiva to recede the anterior lamella and expose the tarsus. Interlamellar separation can be accomplished via a grey line technique, an eyelid crease approach, or a combination of the two
Active Comparator: Bilamellar Tarsal Rotation
Procedure: Bilamellar Tarsal Rotation
the full-thickness transverse blepharotomy combined with everting sutures to rotate the inferior portion of the upper lid outwards and this procedure has a low recurrence risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lid correction
Time Frame: at 1 month post operative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
at 1 month post operative
lid correction
Time Frame: 3 months postoperative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
3 months postoperative
lid correction
Time Frame: 6 months postoperative
Its a subjective outcome that will be collected through an interview after the surgery. it consists of 3 sub domaines which include (adequate correction, undercorrection, and over corrections)
6 months postoperative
Cosmetic Satisfaction
Time Frame: at 1 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
at 1 months post operative
Cosmetic Satisfaction
Time Frame: at 3 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
at 3 months post operative
Cosmetic Satisfaction
Time Frame: at 6 months post operative
Its a subjective outcome that will be collected through an interview after the surgery.
at 6 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)

June 15, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 23, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cicatricial trichiasi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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