Orbital Fat Prolapse
Conditions
Keywords
orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound
Brief summary
Study title * Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design * single arm and Investigator Initiative pilot study
Interventions
DEVICEUltheraTM 100 shots
UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
Sponsors
Ulthera, Inc
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \>20 years, Age \< 50 years * people who want to improve baggy eyelid * Information consent obtained
Exclusion criteria
* previous lower eyelid surgical history * scar on lower eyelid after trauma * bleeding tendency * aesthetic addiction, drug abuse, alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The distance from the inferior orbital rim to the skin | Change from Screening in distance at 12weeks after Ulthera treatment | Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The distance from the most protrusive baggy eyelid to the orbital septum | Change from Screening in distance at 12weeks after UltheraTM treatment | The distance(mm),from the most protrusive baggy eyelid to the orbital septum will be measured by a plastic surgeon with orbital CT films. Each participant will do Orbital CT scan 2 times, at screening and 12weeks after treatment |
| Subject Satisfaction for baggy lower eyelid | Change from Screening in satisfaction at 4 weeks and 12weeks | 5-point scale for Subject Satisfaction in baggy lower eyelid. The subject satisfaction is calculated as a score between 0 and 4( 0= very poor, 4= very good). |
| Improvement of baggy lower eyelid | Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment | Improvement of baggy lower eyelid will be assessed by Two plastic surgeons. Both assessors will evaluate Improvement of baggy lower eyelid including skin laxity and orbital fat prolapse using 5-point scale. 0= no involvement 1. mild 2. moderate 3. marked 4. severe |
Countries
South Korea
Outcome results
None listed