Back to resultsManagment of Tear Trough Deformity
Primary Purpose
Eyelid Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
transconjunctival lower blepharoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Eyelid Diseases focused on measuring tear trough, blepharoplasty,orbital fat
Eligibility Criteria
Inclusion Criteria:
- tear trough deformity
Exclusion Criteria:
- Eyelid diseases and previous eyelid surgery
Sites / Locations
- INMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SVF-gel
fat transposition
Arm Description
Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel)
Transconjunctival blepharoplasty associated with fat transposition
Outcomes
Primary Outcome Measures
skin-periosteal depth
measure skin-periosteal depth
Secondary Outcome Measures
global aesthetic improvement scale
calculate scale score from score 1 (exceptional improvement) to score 5 (worsening patient)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04538716
Brief Title
Managment of Tear Trough Deformity
Official Title
Long Term Efficacy of Different Approaches in the Treatment of Tear Trough Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The tear trough deformity is a challenging cosmetic condition.surgical treatment and filling are good treatment options
Detailed Description
Procedure is lower eyelid transconjunctival Blepharoplasty associated with stromal vascular fraction gel (SVF-gel) or fat transposition
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
tear trough, blepharoplasty,orbital fat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SVF-gel
Arm Type
Experimental
Arm Description
Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel)
Arm Title
fat transposition
Arm Type
Experimental
Arm Description
Transconjunctival blepharoplasty associated with fat transposition
Intervention Type
Procedure
Intervention Name(s)
transconjunctival lower blepharoplasty
Intervention Description
transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)
Primary Outcome Measure Information:
Title
skin-periosteal depth
Description
measure skin-periosteal depth
Time Frame
2 years
Secondary Outcome Measure Information:
Title
global aesthetic improvement scale
Description
calculate scale score from score 1 (exceptional improvement) to score 5 (worsening patient)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
tear trough deformity
Exclusion Criteria:
Eyelid diseases and previous eyelid surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TAREK R ELHAMAKY, MD
Phone
503207889
Ext
+971
Email
dr_thamakyy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
TAREK ELHAMAKY
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TAREK ELHAMAKY, MD
Organizational Affiliation
Benha university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
INMC
City
Abu Dhabi
ZIP/Postal Code
46266
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAREK ELHAMAKY, MD
12. IPD Sharing Statement
Learn more about this trial
Managment of Tear Trough Deformity
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