Ziplyft vs traditional blepharoplasty for upper eyelid rejuvenation

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

This study will test whether Ziplyft or traditional blepharoplasty works better for adults with excess upper eyelid skin by treating one eyelid with Ziplyft and the other with standard surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 35 Years and up
• Sex: All
• Sponsor: Osheru Inc. (Industry-sponsored)
• Locations: 1 site (Oxford, North Carolina)
• Trial ID: NCT07250139 on ClinicalTrials.gov

What this trial studies

This interventional split-face trial enrolls adults undergoing upper eyelid blepharoplasty, with one eyelid treated using the Ziplyft clamp and the opposite eyelid treated with standard blade/cautery and sutures. The Ziplyft side uses mechanical compression to minimize bleeding and is closed with commercially available tissue adhesive, while the comparator side is closed with standard sutures after cautery. The study measures bruising, incision and wound closure characteristics, operative case time, and patient and surgeon survey responses over scheduled follow-up visits. Procedures are performed at a single site in Oxford, North Carolina, with standardized preoperative markings to ensure equivalent tissue removal on both sides.

Who should consider this trial

Good fit: Adults aged 35 or older with excess upper eyelid skin who are cleared for blepharoplasty, can provide informed consent, and can attend required follow-up visits are appropriate candidates.

Not a fit: Patients with a current diagnosis of ptosis, other eyelid functional disorders, or contraindications to the device or tissue adhesive are unlikely to receive benefit from this comparison.

Why it matters

Potential benefit: If successful, Ziplyft could reduce intraoperative bleeding and suturing, shorten operative time, and potentially speed recovery or improve cosmetic outcomes.

How similar studies have performed: Clamping devices and tissue adhesive closure have been described in small series and device reports, but rigorous split-face comparisons of Ziplyft versus standard blepharoplasty are limited.

Eligibility criteria

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 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.

Exclusion Criteria:

1. Subjects with a current Ptosis diagnosis
2. Subjects with a history of Graves' Disease
3. Subjects with Myasthenia Gravis
4. 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).
5. Subjects that have had any previous surgery eyelid or eyebrow region.
6. 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.
7. Active or recent (within 3 months) tobacco user
8. Allergy to adhesive glue
9. 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.
10. Pregnant or nursing females.

Where this trial is running

Oxford, North Carolina

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

Study contacts

• Study coordinator: Patricia Buehler, MD

Conditions Dermatochalasis of Upper Eyelid; Ptosis, Eyelid; Blepharoplasty; Dermatochalasis of upper eyelid, Ptosis of upper eyelid, blepharoplasty,; Ziplyft; upper eyelid surgery