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Minimally Invasive Holmium:YAG Laser Blepharoplasty

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ClinicalTrials.gov Identifier: NCT00842764
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lower Eyelid Entropion Device: eyelid Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Minimally Invasive Holmium:YAG Laser Blepharoplasty
Study Start Date : January 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: eyelid
eyelid
 Device: eyelid
eyelid
Other Name: laser


Outcome Measures
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Primary Outcome Measures :
  1. reducing lower eyelid bags [ Time Frame: 6 months ]
    length and degree of post-operative pain, edema, visual disturbances, ectropion, bruising, and bleeding


Eligibility Criteria
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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