NCT02879552

Brief Summary

Increased tarsal platform show (TPS) and decreased brow fat span (BFS) are associated with favorable results in women undergoing cosmetic blepharoplasty. The authors evaluate the efficacy of a technique (brassiere sutures) to increase TPS and decrease the BFS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

August 21, 2016

Last Update Submit

August 21, 2016

Conditions

Keywords

Upper blepharoplastybrassiere suturestarsal platform showeyeshadow spacebrow fat span

Outcome Measures

Primary Outcomes (1)

  • Eyelid measurements of traditional blepharoplasty and brassiere suture, before and after surgery

    6 months

Secondary Outcomes (1)

  • Asymmetry of TPS and BFS in traditional blepharoplasty and brassiere suture

    6 months

Study Arms (2)

Traditional upper blepharoplasty

Patients with an odd total number of letters in their first name received traditional upper blepharoplasty.

Procedure: Brassiere suture with blepharoplasty

Brassiere suture with blepharoplasty

The rest of the patients received orbicularis oculi muscle fixation to periosteum (brassiere sutures)

Procedure: Traditional upper blepharoplasty

Interventions

The skin incisions were marked using a skin marking pen. Preseptal orbicularis skin and muscle were removed using a size-15 scalpel blade and scissors. Hemostasis was achieved with conservative electrocuatery. The skin was closed with a running 6-0 nylon suture.

Brassiere suture with blepharoplasty

Prior to skin closure as above, three 6-0 polyglactin sutures are passed along the lateral fourth of the orbital rim. The sutures attach the inferior orbicularis oculi edge to the arcus marginalis of lateral ROOF. Sutures are placed until there is a visible "plumping" of the sub-brow tissues.

Traditional upper blepharoplasty

Eligibility Criteria

Age35 Years - 81 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prospective, randomized, observational case series study included 110 eyelids (50 patients) that underwent cosmetic upper blepharoplasty and brassiere suture.

You may qualify if:

  • Female underwent cosmetic upper blepharoplasty and brassiere suture with blepharoplasty

You may not qualify if:

  • History of thyroid eye disease, levator dehiscence ptosis, blepharospasm, facial nerve paresis, a history of previous upper facial surgery or trauma, and postoperative follow-up for less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Figueiredo MN, Tao J, Akaishi P, Limongi RM. Tarsal platform show after upper eyelid blepharoplasty with or without brassiere sutures. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):345-349. doi: 10.5935/0004-2749.20170085.

MeSH Terms

Interventions

Blepharoplasty

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeDermatologic Surgical ProceduresPlastic Surgery Procedures

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2016

First Posted

August 25, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 25, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share