Actively Recruiting
Evaluating Patient-Reported Outcomes and Surgeon Satisfaction With Ziplyft™ for Blepharoplasty
Led by Osheru Inc. · Updated on 2025-08-27
200
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate patient and surgeon-reported outcomes for individuals undergoing blepharoplasty using a device called Ziplyft™. The study focuses on measuring patient satisfaction with facial appearance and eyes, surgeon satisfaction and efficiency, bruising, eyelid symmetry, wound closure success with tissue adhesive, and case time. The study is interventional and monitors these outcomes over a 3-month period following the procedure. Participants will receive treatment with Ziplyft™, a Class 1, 510(k) exempt device designed to remove excess unwanted eyelid skin through a novel surgical method. The procedure is performed once, followed by regular follow-up visits extending up to 3 months to assess various outcomes including the success of wound closure and improvements in eyelid appearance and symmetry. Throughout the study, participants will attend scheduled visits for evaluations that include patient and surgeon feedback, assessments of bruising and eyelid symmetry, and measurements related to wound healing and procedure efficiency. Researchers will track these factors from enrollment through the final visit at 3 months to understand the device's performance and participant satisfaction. Participants are also monitored for any adverse effects and are expected to comply with study instructions and follow-up visits during this time.
CONDITIONS
Brief Title
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed written consent before any study procedures
- Able and willing to follow study instructions and complete all visits
- Male or female adults aged 35 years or older at the preoperative visit
- Willing to return for required follow-up visits
- Have excess eyelid skin and are eligible for the procedure per investigator's opinion
- Female participants must be 1-year postmenopausal, surgically sterilized, or have a negative pregnancy test if of childbearing potential
- Women of childbearing potential must use approved contraception during the study
You will not qualify if you...
- Current diagnosis of ptosis
- History of Graves' Disease
- Diagnosis of Myasthenia Gravis
- Anatomical features not suitable for device use (e.g., heavy brow, severe upper eyelid hollowing, history of ocular trauma)
- Previous eyelid or eyebrow surgery
- Use of anticoagulant medications such as Aspirin or NSAIDs within 7 days, or Xarelto, Warfarin, Enoxaparin, or Plavix within 3 days before the procedure
- Active or recent tobacco use within 3 months
- Allergy to adhesive glue
- Participation in another investigational study within 30 days prior to or during this study
- Pregnant or nursing females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment to the last visit at 3 months
Participants undergo blepharoplasty using the Ziplyft™ device to remove excess eyelid skin.
1 procedure visit and multiple follow-up visits over 3 months
Trial Site Locations
Total: 5 locations
1
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Actively Recruiting
2
Vance Thompson Vision
Alexandria, Minnesota, United States, 56308
Actively Recruiting
3
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
Actively Recruiting
4
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
5
The Eye Centers of Racine and Kenosha, LTD
Kenosha, Wisconsin, United States, 53142
Actively Recruiting
Research Team
P
Patricia Buehler, MD
B
Becky Weathers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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