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Minimally Invasive Holmium:YAG Laser Blepharoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00842764
First received: February 11, 2009
Last updated: October 22, 2014
Last verified: October 2014
  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:


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
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
Montana Compton
Investigators
Principal Investigator: Brian J Wong, M.D,PhD Otolaryngology UCIMC
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00842764     History of Changes
Other Study ID Numbers: NIH/LAMMP RR-01192.
Study First Received: February 11, 2009
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
eyelid fat pads

ClinicalTrials.gov processed this record on November 24, 2014