Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal

January 18, 2021 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge

Medial upper eyelid pad of fat bulge is a common problem. Small incision surgery could be a time-efficient, minimally invasive and scar formation procedure .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Traditional upper eyelid blepharoplasty: an entire length upper eyelid crease followed by proper dissection are applied . identification and removal of medial pad of fat.

Small Incision technique: 4 mm medial upper eyelid small incision followed by proper dissection to gain direct access to the medial fat pad removal

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 Contact

Study Contact Backup

  • Name: Tarek Elahamky

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • upper eyelid medial pad of fat bulge

Exclusion Criteria:

Other eyelid diseases and 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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: upper eyelid blepharoplasty

traditional upper eyelid blepharoplasty : upper eyelid entire length incision followed by proper dissection medially to medial pad fat.

medial pad fat identification and excision. closure of the wound with subcuticular 6/0 vicryl suture
Procedure: upper eyelid blepharoplasty
upper eyelid blepharoplasty
EXPERIMENTAL: small incision technique

medial upper eyelid 4 mm length incision followed by proper dissection medially to medial pad fat.

medial pad fat identification and excision. closure of the wound with interrupted 6/0 vicryl sutures
Procedure: upper eyelid blepharoplasty
upper eyelid blepharoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global aesthetic improvement scale
Time Frame: 3 months
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of surgery
Time Frame: 3 months
time of surgery in minutes measured by stopwatch
3 months

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: Tarek Elahamky, M.D., Benha 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)

October 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 15, 2021

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (ACTUAL)

December 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky 8

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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