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Trial Outcomes & Findings for Minimally Invasive Holmium:YAG Laser Blepharoplasty (NCT NCT00842764)

NCT ID: NCT00842764

Last Updated: 2022-11-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

2 months

Results posted on

2022-11-01

Participant Flow

Participant milestones

Participant milestones
Measure
Holmium:YAG Laser
Subjects with minimally Invasive Holmium:YAG laser Blepharoplasty
Overall Study
STARTED
7
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimally Invasive Holmium:YAG Laser Blepharoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Holmium:YAG Laser
n=7 Participants
Minimally Invasive Holmium:YAG laser Blepharoplasty
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Holmium:YAG Laser
n=5 Participants
Subjects with minimally Invasive Holmium:YAG laser Blepharoplasty
Change in Lower Eyelid Bags.
Preoperative
5 Participants
Change in Lower Eyelid Bags.
Postoperative
5 Participants

Adverse Events

Holmium:YAG Laser

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian J Wong, MD, PhD

Department of Otolaryngology/UCI

Phone: 7144565753

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place