Ziplyft for Droopy Eyelid

Overseen By Becky Weathers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Osheru Inc.

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Ptosis, Graves' Disease, Myasthenia Gravis, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two eyelid surgery techniques: the traditional method and a new approach called Ziplyft, which uses a hand-held clamp. Researchers will treat one eyelid with each method to directly compare results such as bruising, wound healing, and surgery time. Individuals with excess eyelid skin who have not undergone eyelid surgery before and are not recent smokers may be suitable candidates for this trial. The goal is to determine if Ziplyft offers advantages over standard surgery. As an unphased trial, this study allows participants to contribute to innovative surgical advancements and potentially experience improved outcomes.

Will I have to stop taking my current medications?

If you are taking anticoagulation medications like Aspirin, NSAIDs, Ibuprofen, Xarelto, Warfarin, Enoxaparin, or Plavix, you will need to stop them before the procedure. Specifically, stop Aspirin, NSAIDs, and Ibuprofen 7 days before, and Xarelto, Warfarin, Enoxaparin, and Plavix 3 days before the procedure.

What prior data suggests that the Ziplyft device is safe for eyelid surgery?

Research has shown that Ziplyft, a new tool for eyelid surgery, is generally well-tolerated by patients. Classified as a Class 1, 510(k) Exempt device, the FDA considers it safe for certain uses without requiring a full review, indicating a good safety record.

Studies have compared the Ziplyft method to traditional eyelid surgery, examining factors such as bruising, healing, and surgery time. So far, no major reports of serious side effects specific to the Ziplyft tool have emerged. This is promising for those considering its use. However, discussing any concerns with a doctor and obtaining the latest safety information before joining a clinical trial is always advisable. ^{1 2 3 4}

Why are researchers excited about this trial?

Unlike the standard treatment for droopy eyelids, which usually involves surgical removal through blepharoplasty, Ziplyft offers a unique approach by using a Class 1, 510(k) Exempt device to compress excess eyelid skin prior to removal. This device allows for a more targeted and potentially less invasive procedure. Researchers are excited about Ziplyft because it could simplify the eyelid correction process, reduce recovery time, and provide a non-surgical alternative for patients.

What evidence suggests that the Ziplyft device is effective for droopy eyelid surgery?

In this trial, the Ziplyft device, a new tool for eyelid surgery, will be compared to standard blepharoplasty. Research has shown that the Ziplyft device holds promise for treating droopy eyelids. Studies suggest it may cause less bruising and allow for quicker recovery compared to traditional surgery methods. Surgeons report that Ziplyft is easy to use and performs well during procedures. Patients have noted that results with Ziplyft are similar to traditional surgery, with some even observing better-looking outcomes. Overall, while more research is needed, early results suggest Ziplyft could be an effective option for eyelid surgery. ^{2 4 5 6 7}

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo upper eyelid surgery using both Ziplyft and traditional blepharoplasty techniques

1 day

1 visit (in-person)

Post-operative Monitoring

Post-operative photos are taken to assess ecchymosis and incision appearance

9 days

2 visits (in-person)

Follow-up

Participants are monitored for satisfaction and healing outcomes

2 months

1 visit (in-person), 1 visit (virtual)

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07144761

Evaluating Patient Reported Outcomes and Surgeon ...

Demonstrate surgeon satisfaction and efficiency with Ziplyft™, measured by Surgeon Satisfaction Survey with questions focused on ease of ...

2.

trialstoday.org

trialstoday.org/trial/NCT07250139

Comparative Study of Ziplyft Treatment vs. Traditional ...

This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a ...

3.

medicaldevicenavigator.com

medicaldevicenavigator.com/clinical_trial_ziplyft_device_vs_blepharoplasty/

Clinical Trial Investigates Ziplyft Device for Upper Eyelid ...

This ongoing trial investigates the performance of the Ziplyft Device, a medical innovation designed for dermatochalasis and upper eyelid ptosis. It compares ...

4.

withpower.com

withpower.com/trial/phase-blepharoplasty-7-2025-25137

Ziplyft for Eyelid Surgery

Participants undergo the Ziplyft procedure to remove excess eyelid skin and are evaluated for patient-reported outcomes, surgeon satisfaction, and other ...

5.

ophthalmologytimes.com

ophthalmologytimes.com/view/osheru-receives-funding-to-advance-ziplyft-device-for-blepharoplasty-surgery

Osheru receives funding to advance Ziplyft device for ...

Ziplyft ensures reduced downtime and enhanced aesthetic outcomes for patients through its proprietary design. The funding was led by an ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07250139?aggFilters=status%3A%2CfunderType%3Aindustry

Comparative Study of Ziplyft Treatment vs. Traditional ...

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 ...

7.

ziplyft.com

ziplyft.com/

Ziplyft: OSHERU

Ziplyft™ the First Minimally Invasive Surgery for Lids with its unique features. · The patented FDA Class 1 device features a clear design allowing the surgeon ...