TPS After Upper Blepharoplasty

August 21, 2016 updated by: Instituto de Olhos de Goiania

Tarsal Platform Show After Upper Eyelid Blepharoplasty With or Without Brassiere Sutures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, comparative, case series study of 100 eyelids (50 consecutive women patients) treated with cosmetic upper blepharoplasty by a single surgeon. Patients were randomized to receive traditional upper blepharoplasty with a single running suture skin closure versus orbicularis oculi muscle fixation to periosteum (brassiere sutures) prior to skin closure. Patient age, follow-up length, complications and treatment were analyzed. The mean of TPS, BFS and TPS/BFS ratio was measured before and after surgery at 3 anatomic landmarks.

56 eyelids (28 patients) were treated with traditional single suture blepharoplasty and 44 eyelids (22 patients) had brassiere sutures. After surgery, the mean change in TPS was 2.10 mm with brassiere sutures compared to 2.04 mm without (p <.001). The mean change in BFS was 3.33 mm with brassiere sutures compared to 3.19 mm without (p <.001), The mean change in TPS:BFS ratio at all 3 anatomic landmarks was statistically significant in both groups but the change was statistically greater with the use of brassiere sutures (p <.001).

Brassiere sutures during upper blepharoplasty were associated with a postoperative increase in TPS decrease in BFS, and increase in TPS/BFS.

Study Type

Observational

Enrollment (Actual)

2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Female underwent cosmetic upper blepharoplasty and brassiere suture with blepharoplasty

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional upper blepharoplasty
Patients with an odd total number of letters in their first name received traditional upper blepharoplasty.
Procedure: 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.
Brassiere suture with blepharoplasty
The rest of the patients received orbicularis oculi muscle fixation to periosteum (brassiere sutures)
Procedure: Traditional upper blepharoplasty
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Eyelid measurements of traditional blepharoplasty and brassiere suture, before and after surgery
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Asymmetry of TPS and BFS in traditional blepharoplasty and brassiere suture
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Olhos de Goiania

Collaborators

Centro de Referência em Oftalmologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 21, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

August 21, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MR-01-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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