NCT04538716

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

4.3 years

First QC Date

August 31, 2020

Last Update Submit

November 12, 2023

Conditions

Eyelid Diseases

Keywords

tear trough, blepharoplasty,orbital fat

Outcome Measures

Primary Outcomes (1)

  • skin-periosteal depth

    measure skin-periosteal depth

    2 years

Secondary Outcomes (1)

  • global aesthetic improvement scale

    2 years

Study Arms (2)

SVF-gel

EXPERIMENTAL

Transconjunctival blepharoplasty associated with associated with stromal vascular fraction gel (SVF-gel)

Procedure: transconjunctival lower blepharoplasty

fat transposition

EXPERIMENTAL

Transconjunctival blepharoplasty associated with fat transposition

Procedure: transconjunctival lower blepharoplasty

Interventions

transconjunctival lower blepharoplastyPROCEDURE

transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)

SVF-gelfat transposition

Eligibility Criteria

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

You may qualify if:

  • tear trough deformity

You may not qualify if:

  • 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

Location

Related Publications (1)

  • Elhamaky TR. Orbital fat graft retroseptal transconjunctival blepharoplasty for treatment of groove in the infraorbital region. Int Ophthalmol. 2024 May 6;44(1):217. doi: 10.1007/s10792-024-03148-z.

    PMID: 38705907DERIVED

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • TAREK ELHAMAKY, MD

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

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

August 31, 2020

First Posted

September 4, 2020

Study Start

August 1, 2019

Primary Completion

November 1, 2023

Study Completion

November 10, 2023

Last Updated

November 15, 2023

Record last verified: 2023-11

Locations

AE(1)