Minimally Invasive Holmium:YAG Laser Blepharoplasty

This study has been completed.

Sponsor:

Collaborator:

Beckman Laser Institute University of California Irvine

Information provided by (Responsible Party):

Beckman Laser Institute and Medical Center, University of California, Irvine

ClinicalTrials.gov Identifier:

NCT00842764

First received: February 11, 2009

Last updated: August 5, 2015

Last verified: August 2015

History of Changes

Purpose

The purpose of this research study is to is to evaluate the safety and effectiveness of the FDA approved Holmium:YAG laser for reducing lower eyelid bags.

Condition	Intervention	Phase
Lower Eyelid Entropion	Device: eyelid	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Minimally Invasive Holmium:YAG Laser Blepharoplasty

Resource links provided by NLM:

Drug Information available for: Holmium

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

reducing lower eyelid bags [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]


Enrollment:	7
Study Start Date:	January 2009
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: eyelid eyelid	Device: eyelid eyelid Other Name: laser

Detailed Description:

The researchers are interested in learning if the more precise Holmium:YAG laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.

Eligibility


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

male/female 30 years and older
have pronounced lower eyelid fat pads.

Exclusion Criteria:

based on medical problems.
Previous surgery or trauma to lower eyelid or orbit.
pregnant or lactating.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842764

Locations


United States, California
UCIMC
Orange, California, United States, 92868

Sponsors and Collaborators

University of California, Irvine

Beckman Laser Institute University of California Irvine

Investigators


Principal Investigator:	Brian J Wong, M.D,PhD	Otolaryngology, UCIMC

More Information


Responsible Party:	Beckman Laser Institute and Medical Center, Brian Wong, M.D., Ph.D., Professor Department of Otolaryngology, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00842764 History of Changes
Other Study ID Numbers:	NIH/LAMMP-2008-6593
Study First Received:	February 11, 2009
Last Updated:	August 5, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:


eyelid fat pads

Additional relevant MeSH terms:


Entropion Eyelid Diseases Eye Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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