Minimally Invasive Holmium:YAG Laser Blepharoplasty

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00842764

First Posted: February 12, 2009

Last Update Posted: February 10, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Beckman Laser Institute University of California Irvine

Information provided by (Responsible Party):

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

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:	Intervention Model: Single Group Assignment Masking: None (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 Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:

reducing lower eyelid bags [ Time Frame: 6 months ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted:	February 11, 2009
First Posted:	February 12, 2009
Last Update Posted:	February 10, 2017
Last Verified:	February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:


eyelid fat pads

Additional relevant MeSH terms:


Entropion Eyelid Diseases Eye Diseases

To Top