Actively Recruiting
Comparative Study of Ziplyft Device Versus Standard Blepharoplasty for Upper Eyelid Rejuvenation
Led by Osheru Inc. · Updated on 2025-11-26
50
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two surgical methods for upper eyelid surgery called blepharoplasty, which removes excess skin that can affect peripheral vision and appearance. The study uses a split-face design where one eyelid undergoes traditional surgery using a blade, cautery, and sutures, while the other eyelid is treated with Ziplyft, a clamp device that compresses the skin to prevent bleeding and uses tissue adhesive instead of sutures. The goal is to evaluate bruising, wound healing, surgery time, and satisfaction from both patients and surgeons. Participants will have one eyelid treated with standard blepharoplasty involving blade removal, blood vessel cautery, and suturing, and the other eyelid treated with Ziplyft which compresses skin to stop bleeding, allowing incision closure with tissue adhesive. Both sides will have equal amounts of skin removed. The surgeon will record the time taken for each procedure. Follow-up photos will be taken at 3, 7 days, and 1 month after surgery to assess bruising and incision healing. During the study, participants will be evaluated with independent professional review of post-operative photos to measure bruising and incision appearance. Both patient and surgeon surveys will capture satisfaction levels up to two months after surgery. The study tracks wound closure success and compares surgical case times. Follow-up visits and evaluations will ensure comprehensive monitoring of outcomes and participant experience.
CONDITIONS
Brief Title
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed written consent before any study procedures.
- Ability and willingness to follow study instructions and complete all visits.
- Male or female adults aged 35 years or older at preoperative visit.
- Excess eyelid skin suitable for surgery as determined by the investigator.
- 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 acceptable contraception throughout the study.
You will not qualify if you...
- Current diagnosis of ptosis.
- History of Graves' Disease.
- Diagnosis of Myasthenia Gravis.
- Anatomical issues preventing device use (e.g., heavy brow, severe eyelid hollowing, ocular trauma).
- Previous eyelid or eyebrow surgery.
- Use of anticoagulation therapy within specified days before surgery.
- Active or recent tobacco use within 3 months.
- Allergy to adhesive glue.
- Participation in other investigational studies within 30 days before or during this study.
- Pregnancy or nursing.
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.
1 visit (in-person)
Duration - Surgery day plus up to 2 months post-operation
Participants undergo upper eyelid surgery where one side is treated with the Ziplyft device and the other side with standard blepharoplasty involving sutures.
1 surgical visit followed by visits on Day 3, Day 7, and approximately 1 and 2 months post-operation
Trial Site Locations
Total: 1 location
1
New Century Ophthalmology
Oxford, North Carolina, United States, 27585
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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