Lower Eyelid Entropion
Conditions
Keywords
eyelid fat pads
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.
Detailed 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.
Interventions
PROCEDUREHolmium: YAG laser
Minimally Invasive Holmium:YAG laser Blepharoplasty
Sponsors
Beckman Laser Institute University of California Irvine
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Eyelid Bags. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Holmium:YAG Laser Minimally Invasive Holmium:YAG laser Blepharoplasty | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Holmium:YAG Laser |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: 2 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Holmium:YAG Laser | Change in Lower Eyelid Bags. | Preoperative | 5 Participants |
| Holmium:YAG Laser | Change in Lower Eyelid Bags. | Postoperative | 5 Participants |