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

Osheru Inc.

Status: Enrolling

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

Treatments: Device: Ziplyft Device; Other: Comparator Arm: Standard Blepharoplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT07250139

25592-Osheru

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Comparing Ziplyft Device Treatment to Standard Blepharoplasty

Experimental group

Description:

Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Standard blepharoplasty will be performed on the fellow side of the participant's face.

Treatment:

Other: Comparator Arm: Standard Blepharoplasty

Device: Ziplyft Device