Minimally Invasive Holmium:YAG Laser Blepharoplasty

Not Applicable

Completed

• Conditions: Lower Eyelid Entropion

• Registration Number: NCT00842764
• Lead Sponsor: University of California, Irvine

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2018-02-06
• Results First Submitted QC: 2019-02-21
• Results First Posted: 2019-03-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Lower Eyelid Bags.	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.

Trial Locations

Locations (1)

UCIMC; 🇺🇸 Orange, California, United States