NCT05016362

Brief Summary

Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

December 24, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

August 17, 2021

Last Update Submit

August 17, 2021

Conditions

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

    1 year

Study Arms (2)

Group A

blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery.

Procedure: medial fat preservation upper blepharoplasty

Group B

blepharoplasty with repositioning of the nasal fat pad to orbitoglabellar groove during surgery.

Procedure: medial fat preservation upper blepharoplasty

Interventions

medial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold

Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

at least 18 years old participant with dermtochlasis

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

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek R Elahamky, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2021

First Posted

August 23, 2021

Study Start

December 24, 2020

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations