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OpenTrials
Completed

NCT Number: NCT00842764

Minimally Invasive Holmium:YAG Laser Blepharoplasty

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.

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Key information

Conditions

Lower Eyelid Entropion

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCIMC

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holmium: YAG laser

Procedure

Minimally Invasive Holmium:YAG laser Blepharoplasty

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Beckman Laser Institute University of California Irvine

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 12, 2009
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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