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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
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• 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.

Locations
United States
North Carolina
New Century Ophthalmology
RECRUITING
Oxford
Contact Information
Primary
Patricia Buehler, MD
pbuehler@osheru.com
541-419-4412
Backup
Becky Weathers
bweathers@osheru.com
541-312-4622
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 50
Treatments
Experimental: Comparing Ziplyft Device Treatment to Standard Blepharoplasty
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.
Related Therapeutic Areas
Sponsors
Leads: Osheru Inc.

This content was sourced from clinicaltrials.gov