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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00347308
Other study ID # 001
Secondary ID
Status Completed
Phase N/A
First received June 29, 2006
Last updated April 29, 2012
Start date July 2007
Est. completion date January 2009

Study information

Verified date April 2012
Source The New York Eye & Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Forehead and eyebrow surgery is a frequently performed cosmetic surgical procedure in which the eyebrows are raised to a more aesthetically pleasing position. Typically, this position is judged by the surgeon pre-operatively based on traditional aesthetic concepts, some of which date to the Classical era. This study is designed to assess the variance of the eyebrow from the desired aesthetic position (as determined by the subject), as wel as to assess the distance of normal excursion of the brow from maximum voluntary depression to maximum voluntary elevation.


Description:

A set of 5 digital photographs will be taken of 100 (30 male, 70 female) adult study participants. Prior to photography, water soluble ink will be used to mark the inferior aspect of the superior orbital rim above the medial and lateral canthi and in the mid pupillary line. Photographs taken will image patients from crown to chin and will be taken with eyes open and closed, brows raised, maximally contracted and at rest. A final photograph will be taken with the subject manually holding both brows in the position he/she finds most aesthetically pleasing as seen in a mirror. During all photography, a ruler will be held against the face for later calibration, all photographs will be taken with a camera mounted flash and with the patient in a Frankfort horizontal plane. All photographs will be analyzed with proprietary computer software.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- adults,

- aged 18-85 years

Exclusion Criteria:

- prior forehead, eyebrow or eyelid surgery,

- neurotoxin treatment to the forehead or eyes within the past 6 months,

- injectable soft tissue filler used within the last 12 months,

- photosensitivity.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Eyebrow Position
Photography of brow positions

Locations

Country Name City State
United States Center for Facial Plastic Surgery Chappaqua New York

Sponsors (1)

Lead Sponsor Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eyebrow Position Position of eyebrow at the medial canthus relative to orbital rim At time of evaluation No
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