NCT04689230

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

December 28, 2020

Last Update Submit

January 18, 2021

Conditions

Eyelid Diseases

Keywords

upper eyelid pad fatblepharoplasty

Outcome Measures

Primary Outcomes (1)

  • global aesthetic improvement scale

    calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient

    3 months

Secondary Outcomes (1)

  • duration of surgery

    3 months

Study Arms (2)

upper eyelid blepharoplasty

ACTIVE COMPARATOR

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

small incision technique

EXPERIMENTAL

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

Interventions

upper eyelid blepharoplastyPROCEDURE

upper eyelid blepharoplasty

small incision techniqueupper eyelid blepharoplasty

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • upper eyelid medial pad of fat bulge

You may not qualify if:

  • Other eyelid diseases and previous eyelid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Tarek Elahamky, M.D.

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek R Elahamky, M.D.

CONTACT

503207889dr_thamakyy@yahoo.com

Tarek Elahamky

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 30, 2020

Study Start

October 1, 2020

Primary Completion

November 1, 2021

Study Completion

November 15, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

AE(1)