Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

January 26, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

Study Type

Interventional

Enrollment (Anticipated)

40

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Lower eyelid involutional entropion
  2. dermatochalasis

Exclusion Criteria:

  1. Other eyelid disease,
  2. Other causes of entropion
  3. Previous eyelid surgery

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: triple procedure
lower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection
Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection
combined lower eyelid blepharoplasty , retractor plication and wedge resection
Procedure: lower eyelid blepharoplasty and retractor plication
combined lower eyelid blepharoplasty and retractor plication procedures
Active Comparator: combined procedure
lower eyelid retractors plication and transcutaneous blepharoplasty
Procedure: lower eyelid blepharoplasty , retractor plication and wedge resection
combined lower eyelid blepharoplasty , retractor plication and wedge resection
Procedure: lower eyelid blepharoplasty and retractor plication
combined lower eyelid blepharoplasty and retractor plication procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale
Time Frame: 12 months
calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient
12 months

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Tarek R Elahamky, MD, Benaha university faculty of medicine

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)

August 1, 2020

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky9

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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