Minimally Invasive Holmium:YAG Laser Blepharoplasty

Lower Eyelid Entropion Clinical Trial

Official title:

Minimally Invasive Holmium:YAG Laser Blepharoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842764
• Other study ID #: 20086593
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Entropion
• Lower Eyelid Entropion

Intervention

Procedure:
• Holmium: YAG laser
Minimally Invasive Holmium:YAG laser Blepharoplasty

Locations

Country	Name	City	State
United States	UCIMC	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months