An interventional study of Holmium: YAG laser in Lower Eyelid Entropion, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-01.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
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.
University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will go under minimally invasive Holmium: YAG laser blepharoplasty
Procedure: Holmium: YAG laser
Minimally Invasive Holmium:YAG laser Blepharoplasty
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.
Time frame: 2 months
| Milestone | Holmium:YAG Laser |
|---|---|
| Started | 7 |
| Completed | 5 |
| Not completed | 2 |
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.
| Participants | Holmium:YAG Laser |
|---|---|
| Preoperative | 5 |
| Postoperative | 5 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Holmium:YAG Laser | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Holmium:YAG Laser |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Holmium:YAG Laser |
|---|---|
| Female | 3 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Holmium:YAG Laser |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Holmium:YAG Laser |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Entropion
University of California, Irvine