Retroseptal Transconjunctival Blepharoplasty for GIR

November 12, 2023 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

Orbital Fat Graft Retroseptal Transconjunctival Blepharoplasty for Treatment of Groove in the Infraorbital Region

The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition

Study Type

Interventional

Enrollment (Actual)

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • tear trough deformity

Exclusion Criteria:

  • 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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SVF-gel
Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel)
Procedure: transconjunctival lower blepharoplasty
transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)
Experimental: fat transposition
Transconjunctival blepharoplasty associated with fat transposition
Procedure: transconjunctival lower blepharoplasty
transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin-periosteal depth
Time Frame: 2 years
measure skin-periosteal depth
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global aesthetic improvement scale
Time Frame: 2 years
calculate scale score from score 1 (exceptional improvement) to score 5 (worsening patient)
2 years

Collaborators and Investigators

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

Sponsor

Benha University

Investigators

  • Principal Investigator: TAREK ELHAMAKY, MD, 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)

August 1, 2019

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky6

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.

Clinical Trials on Eyelid Diseases

Clinical Trials on transconjunctival lower blepharoplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe