NCT07250139

Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Osheru Inc. · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 side, the exact same amount of tissue that was marked prior to the surgery will be removed. The fellow (second) side will use a clamp (Ziplyft) to compress the excess skin prior to removal so that there is no bleeding and therefore no need for cautery to seal blood vessels. The same amount of tissue will be removed on this second side; it will be all the marked tissue. As the clamp compresses the excess skin and seals it together, no suturing is required, and the incision can be closed with tissue adhesive which has been used for many years to close eyelid surgery incisions. Using the commercially available tissue adhesive eliminates the need for sutures to close the incision. Both right and left upper eyelids will have the same amount of tissue removed, similar to standard blepharoplasty surgery. Both sides will also have incisions; one will be closed with sutures, and the other will be closed with tissue adhesive. In summary, both right and left upper eyelids are getting a standard blepharoplasty procedure. One side is utilizing a clamp (Ziplyft) to eliminate bleeding and the need for sutures. The surgeon will record case time for Ziplyft side and traditional blepharoplasty side. Post-op photos taken at day 3 and 7 will be used to assess ecchymosis (bruising) by a masked, independent professional (physician). Photos taken at 7 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by a masked, independent professional (physician). Participant- and surgeon-reported surveys will be used to evaluate satisfaction with the Ziplyft procedure and outcome.

Conditions

• Dermatochalasis of Upper Eyelid
• Ptosis, Eyelid
• Blepharoplasty

Interventions

Type	Name	Description
DEVICE	Ziplyft 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.
OTHER	Comparator 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.

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-05-31
• Completion: 2026-09-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study