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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:


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

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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