Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Osheru Inc.
Summary
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft, allowing a direct side-by-side comparison. The objectives of the study are to compare Ziplyft treatment vs. traditional surgery by evaluating bruising, wound closure and incision, surgery case time, and subject/surgeon surveys.
Description
Blepharoplasty (upper eyelid surgery), is a procedure where excess upper eyelid skin that can interfere with peripheral vision is removed, resulting in improvement in peripheral vision and a more revitalized appearance. The amount of excess skin to be removed from each lid is marked symmetrically on both right and left sides just as it is in a standard blepharoplasty. The difference in this comparative study is that one side will be done using a blade, cautery to seal blood vessels, and sutures to close the incision which is how a standard blepharoplasty procedure is performed. On the other si…
Eligibility
- Age range
- 35+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provide signed written consent prior to participation in any study-related procedures. 2. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. 3. Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits. 4. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator. 5. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at th…
Interventions
- DeviceZiplyft Device
Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Ziplyft compresses the excess skin and seals it together, no suturing is required, and the surgery incision will be closed with tissue adhesive.
- OtherComparator Arm: Standard Blepharoplasty
Standard blepharoplasty will be used on the fellow side of the participant's face. Standard blepharoplasty uses a blade, cautery to seal blood vessels, and sutures to close the incision.
Location
- New Century OphthalmologyOxford, North Carolina