Ziplyft for Droopy Eyelid

Overseen By Becky Weathers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Osheru Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals with droopy eyelids who require surgery. Participants must be suitable candidates for both traditional blepharoplasty and the Ziplyft device treatment, allowing one of each to be applied to their eyelids.

Inclusion Criteria

Provide signed written consent prior to participation in any study-related procedures

Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator

I am 35 or older and can attend all required follow-up visits.

Exclusion Criteria

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)

Active or recent (within 3 months) tobacco user

Allergy to adhesive glue

What Are the Treatments Tested in This Trial?

Interventions

• Ziplyft Treatment

Trial Overview The study compares two upper eyelid surgery techniques: traditional blepharoplasty versus the newer Ziplyft method. Each participant's eyes will receive different treatments (one eye per method) for direct comparison of results.

How Is the Trial Designed?

Group I: Comparing Ziplyft Device Treatment to Standard Blepharoplasty Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Osheru Inc.

Lead Sponsor