Photographic Assessment of Eyebrow Position and Range of Motion

• Sponsor: The New York Eye & Ear Infirmary (Other)
• Overall Status: Completed
• CT.gov ID: NCT00347308
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 18.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brow Ptosis	Behavioral: Eyebrow Position

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Time Perspective: Prospective
• Official Title: Photographic Assessment of Eyebrow Position and Range of Motion
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Outcome Measures

Primary Outcome Measures

1. Eyebrow Position [At time of evaluation]

   Position of eyebrow at the medial canthus relative to orbital rim

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Facial Plastic Surgery	Chappaqua	New York	United States	10514

Sponsors and Collaborators

• The New York Eye & Ear Infirmary

Investigators

• Principal Investigator: Anthony P Sclafani, MD, The New York Eye & Ear Infirmary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary
• ClinicalTrials.gov Identifier: NCT00347308
• Other Study ID Numbers: 001
• First Posted: Jul 4, 2006
• Last Update Posted: May 3, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Anthony P. Sclafani, Director of Facial Plastic Surgery, The New York Eye & Ear Infirmary: brow ptosis, facial aesthetics, browlift, facelift
• Additional relevant MeSH terms: Prolapse

Study Results

Participant Flow

Arm/Group Title	Group 1
Arm/Group Description	All patients entered into the study
Period Title: Overall Study
STARTED	40
COMPLETED	40
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description	All patients entered into the study
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	40 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (12.5)
Sex: Female, Male (Count of Participants)
Female	28 70%
Male	12 30%
Region of Enrollment (participants) [Number]
United States	40 100%

Outcome Measures

1. Primary Outcome

Title	Eyebrow Position
Description	Position of eyebrow at the medial canthus relative to orbital rim
Time Frame	At time of evaluation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1
Arm/Group Description	All patients entered into the study
Measure Participants	40
Mean (Standard Deviation) [mm]	-3.22 (1.91)

Adverse Events

Arm/Group Title	Group 1
Arm/Group Description	All patients entered into the study
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.