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Minimally Invasive Holmium:YAG Laser Blepharoplasty

Primary Purpose

Lower Eyelid Entropion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Holmium: YAG laser
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Eyelid Entropion focused on measuring eyelid fat pads

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCIMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Holmium: YAG laser

Arm Description

Subjects will go under minimally invasive Holmium: YAG laser blepharoplasty

Outcomes

Primary Outcome Measures

Change in Lower Eyelid Bags.
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 Outcome Measures

Full Information

First Posted
February 11, 2009
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00842764
Brief Title
Minimally Invasive Holmium:YAG Laser Blepharoplasty
Official Title
Minimally Invasive Holmium:YAG Laser Blepharoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Eyelid Entropion
Keywords
eyelid fat pads

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holmium: YAG laser
Arm Type
Experimental
Arm Description
Subjects will go under minimally invasive Holmium: YAG laser blepharoplasty
Intervention Type
Procedure
Intervention Name(s)
Holmium: YAG laser
Intervention Description
Minimally Invasive Holmium:YAG laser Blepharoplasty
Primary Outcome Measure Information:
Title
Change in Lower Eyelid Bags.
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J Wong, M.D,PhD
Organizational Affiliation
Otolaryngology, UCIMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCIMC
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

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Minimally Invasive Holmium:YAG Laser Blepharoplasty

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