NCT00842764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 4, 2019

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

5.7 years

First QC Date

February 11, 2009

Results QC Date

February 6, 2018

Last Update Submit

October 28, 2022

Conditions

Lower Eyelid Entropion

Keywords

eyelid fat pads

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Holmium: YAG laser

EXPERIMENTAL

Subjects will go under minimally invasive Holmium: YAG laser blepharoplasty

Procedure: Holmium: YAG laser

Interventions

Holmium: YAG laserPROCEDURE

Minimally Invasive Holmium:YAG laser Blepharoplasty

Holmium: YAG laser

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male/female 30 years and older
  • have pronounced lower eyelid fat pads.

You may not qualify if:

  • based on medical problems.
  • Previous surgery or trauma to lower eyelid or orbit.
  • pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCIMC

Orange, California, 92868, United States

Location

MeSH Terms

Interventions

Lasers, Solid-State

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title
Brian J Wong, MD, PhD
Organization
Department of Otolaryngology/UCI
bjwong@uci.edu
7144565753

Study Officials

  • Brian J Wong, M.D,PhD

    Otolaryngology, UCIMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Brian Wong, M.D., Ph.D., Professor Department of Otolaryngology

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 1, 2022

Results First Posted

March 4, 2019

Record last verified: 2022-10

Locations

US(1)