Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid

Study Overview
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Brief Summary
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Study title Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design single arm and Investigator Initiative pilot study

Official Title
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Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.

Conditions
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Orbital Fat Prolapse

Intervention / Treatment
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* Device: UltheraTM 100 shots


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UltheraTM<br>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 | Device: UltheraTM 100 shots<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance from the inferior orbital rim to the skin | Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment | Change from Screening in distance at 12weeks after Ulthera treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance from the most protrusive baggy eyelid to the orbital septum | 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 | Change from Screening in distance at 12weeks after UltheraTM treatment | 
| Subject Satisfaction for baggy lower eyelid | 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). | Change from Screening in satisfaction at 4 weeks and 12weeks | 
| Improvement of baggy lower eyelid | 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 mild moderate marked severe | Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orbital Computed Tomography, baggy eyelids, orbital fat prolapse, UltheraTM, high intensity focused ultrasound