Back to resultsSmall Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal
Primary Purpose
Eyelid Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
upper eyelid blepharoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Eyelid Diseases focused on measuring upper eyelid pad fat, blepharoplasty
Eligibility Criteria
Inclusion Criteria:
- upper eyelid medial pad of fat bulge
Exclusion Criteria:
Other eyelid diseases and previous eyelid surgery
Sites / Locations
- INMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
upper eyelid blepharoplasty
small incision technique
Arm Description
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
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
Outcomes
Primary Outcome Measures
global aesthetic improvement scale
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
Secondary Outcome Measures
duration of surgery
time of surgery in minutes measured by stopwatch
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04689230
Brief Title
Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal
Official Title
Comparison of the Efficacy Between Small Incision Technique and Upper Blepharoplasty in Treatment of Upper Eyelid Medial Pad Fat Bulge
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 15, 2021 (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
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 .
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
upper eyelid pad fat, blepharoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
upper eyelid blepharoplasty
Arm Type
Active Comparator
Arm Description
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
Arm Title
small incision technique
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
upper eyelid blepharoplasty
Intervention Description
upper eyelid blepharoplasty
Primary Outcome Measure Information:
Title
global aesthetic improvement scale
Description
calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient
Time Frame
3 months
Secondary Outcome Measure Information:
Title
duration of surgery
Description
time of surgery in minutes measured by stopwatch
Time Frame
3 months
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:
upper eyelid medial pad of fat bulge
Exclusion Criteria:
Other eyelid diseases and previous eyelid surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek R Elahamky, M.D.
Phone
503207889
Ext
+971
Email
dr_thamakyy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Elahamky
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Elahamky, M.D.
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 R ELHAMAKY, MD
12. IPD Sharing Statement
Learn more about this trial
Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal
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