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

NCT07250139 | Recruiting DMC FDA Device

• 1 other identifier: 25592-Osheru
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dermatochalasis of Upper Eyelid; Ptosis, Eyelid; Blepharoplasty

Keywords

Dermatochalasis of upper eyelid, Ptosis of upper eyelid, blepharoplasty,; Ziplyft; upper eyelid surgery

Outcome Measures

Primary Outcomes (5)

• Compare surgical case time for Ziplyft treatment versus standard blepharoplasty

  The surgeon will record the surgical case times for Ziplyft and standard blepharoplasty. For the Ziplyft side of the participant's face the surgical case time begins when the Ziplyft device touches the patient lid and ends 1 min after adhesive is applied as that is when it has cured. For the standard blepharoplasty side of the participant's face the surgical case time begins as the blade begins its first cut and ends once ointment has been applied.

  From the beginning of the surgical case until surgery has been completed

• Document post-operative ecchymosis with Ziplyft and standard blepharoplasty

  Ecchymosis will be measured by post-operative photographs taken at day 3 and day 7. Photos will be rated on a 1-4 scale for ecchymosis by an independent masked observer (physician).

  3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)

• Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.

  Photos taken at 9 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by an independent masked observer (physician).

  9 days (± 3 days) to up to 2 months (± 1 month) post-operation

• Assess patient reported outcomes with Ziplyft versus standard blepharoplasty

  Patient satisfaction questionnaires regarding comfort, satisfaction, and healing experience will be administered to the participants on the day of surgery and at 2 months post operation.

  After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation

• Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty

  A surgeon-reported questionnaire regarding the procedure efficiency, bleeding, and the use of cautery and suture will be administered following the surgical procedure. A second surgeon-reported questionnaire regarding the use of adhesive, bruising, swelling, scaring, and symmetry will be administered at 2-months post operation.

  The day of surgery until 2 months (± 1 month) post-operation

Study Arms (1)

Comparing Ziplyft Device Treatment to Standard Blepharoplasty

EXPERIMENTAL

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.

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

Interventions

Ziplyft Device 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.

Comparing Ziplyft Device Treatment to Standard Blepharoplasty

Comparator Arm: Standard Blepharoplasty OTHER

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.

Comparing Ziplyft Device Treatment to Standard Blepharoplasty

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Osheru Inc.: lead

Study Sites (1)

New Century Ophthalmology

Oxford, North Carolina, 27585, United States

RECRUITING

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Central Study Contacts

Patricia Buehler, MD

CONTACT

541-419-4412; pbuehler@osheru.com

Becky Weathers

CONTACT

541-312-4622; bweathers@osheru.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be conducted using a "split-face" design. For each participant, one eyelid will be treated with the traditional blepharoplasty method and the other with Ziplyft, allowing a direct side-by-side comparison.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)