Minimally Invasive Holmium:YAG Laser Blepharoplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00842764
First received: February 11, 2009
Last updated: December 9, 2013
Last verified: December 2013
  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 Fat
Procedure: Holmium:YAG laser
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 ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eyelid fat Procedure: Holmium:YAG laser
blepharoplasty
Other Name: blepharoplasty

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
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: LAMMP RR-01192.
Study First Received: February 11, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014