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

Recruiting now · Not applicable

Conditions studied: Dermatochalasis of Upper Eyelid, Ptosis, Eyelid, Blepharoplasty

In brief

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.

Key facts

Study ID: NCT07250139
Run by: Osheru Inc.
People needed: 50
Starts: 2025-12-08
Expected to finish: 2026-09-30
Last updated by the study team: 2025-11-26

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provide signed written consent prior to participation in any study-related procedures.
Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

You may not qualify if…

Subjects with a current Ptosis diagnosis
Subjects with a history of Graves' Disease
Subjects with Myasthenia Gravis
Subjects that in the opinion of the investigator are anatomically not conducive to using devices (e.g., heavy brow, severe hollowing of the upper eyelid, history of ocular or orbital trauma).
Subjects that have had any previous surgery eyelid or eyebrow region.
Use of anticoagulation therapy, including, but not limited to Aspirin, NSAIDS, Ibuprofen within 7 days and Xarelto, Warfarin, Enoxaparin, Plavix within 3 days prior to planned study procedure.
Active or recent (within 3 months) tobacco user
Allergy to adhesive glue
Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
Pregnant or nursing females.

Where it is running

New Century Ophthalmology — Oxford, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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