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

Primary Purpose

Cicatricial Trichiasis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Anterior Lamellar Recession

Bilamellar Tarsal Rotation

About this trial

This is an interventional treatment trial for Cicatricial Trichiasis

Eligibility Criteria

48 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ehab tharwat

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Anterior Lamellar Recession

Bilamellar Tarsal Rotation

Arm Description

Outcomes

Primary Outcome Measures

lid correction

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)

lid correction

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)

lid correction

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)

Cosmetic Satisfaction

Its a subjective outcome that will be collected through an interview after the surgery.

Cosmetic Satisfaction

Its a subjective outcome that will be collected through an interview after the surgery.

Cosmetic Satisfaction

Its a subjective outcome that will be collected through an interview after the surgery.

Secondary Outcome Measures

Full Information

NCT ID

NCT05634629

First Posted

November 23, 2022

Last Updated

November 23, 2022

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05634629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

November 1, 2022 (Actual)

Study Completion Date

November 10, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatricial Trichiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Anterior Lamellar Recession

Arm Type

Active Comparator

Arm Title

Bilamellar Tarsal Rotation

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Anterior Lamellar Recession

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Bilamellar Tarsal Rotation

Intervention Description

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

Primary Outcome Measure Information:

Title

lid correction

Description

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)

Time Frame

at 1 month post operative

Title

lid correction

Description

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)

Time Frame

3 months postoperative

Title

lid correction

Description

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)

Time Frame

6 months postoperative

Title

Cosmetic Satisfaction

Description

Its a subjective outcome that will be collected through an interview after the surgery.

Time Frame

at 1 months post operative

Title

Cosmetic Satisfaction

Description

Its a subjective outcome that will be collected through an interview after the surgery.

Time Frame

at 3 months post operative

Title

Cosmetic Satisfaction

Description

Its a subjective outcome that will be collected through an interview after the surgery.

Time Frame

at 6 months post operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

48 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Undecided

Learn more about this trial

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

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