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Clinical Trials/NCT00842764
NCT00842764CompletedNot Applicable

Minimally Invasive Holmium:YAG Laser Blepharoplasty

University of California, Irvine2 sites in 1 country7 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Change in Lower Eyelid Bags.

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Change in Lower Eyelid Bags.

Time Frame: 2 months

Preoperative and postoperative (postoperative visits were at day 1, 1 week, 1 month, and 2 months) .photographs were evaluated by 6 surgeons on a 5-point Likert scale which 1 indicates worsening, 2 means unchanged, 3 is mild improvement, 4 is moderate improvement, and 5 indicates complete correction.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beckman Laser Institute and Medical Center

Brian Wong, M.D., Ph.D., Professor Department of Otolaryngology

University of California, Irvine

Study Sites (2)

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