Ziplyft for Eyelid Surgery

Recruiting at 4 trial locations

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: Unknown

Duration: 3 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Ziplyft, a new device for eyelid surgery, to evaluate its effectiveness and gather feedback from patients and surgeons. Researchers examine factors such as bruising, the evenness of eyelid healing, and the duration of the surgery. It targets individuals with excess eyelid skin seeking removal. Participants should not have specific eye conditions like ptosis (droopy eyelid) or a history of eyelid surgery. As an unphased trial, this study allows participants to contribute to innovative research in eyelid surgery.

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 is a low-risk device approved by the FDA. It assists surgeons in removing extra eyelid skin by providing a clear view of the area, which can reduce mistakes and enhance safety during surgery.

The approval of Ziplyft as a low-risk device offers some confidence in its safety for eyelid surgery. Studies have not identified any major safety concerns with Ziplyft. The device aims to streamline the surgery process for both patients and doctors, indicating it is generally well-tolerated. However, like any medical procedure, minor risks may still exist. Always consult a healthcare professional before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ziplyft is unique because it offers a non-invasive device option for removing excess eyelid skin, unlike traditional surgical methods like blepharoplasty. This Class 1, 510(k) Exempt device is designed to streamline the procedure, potentially reducing recovery time and minimizing the risks associated with surgical interventions. Researchers are excited about Ziplyft because it could provide a safer, more accessible alternative for patients seeking eyelid rejuvenation without the need for surgery.

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

Studies have shown that Ziplyft, the treatment tested in this trial, offers a less invasive option compared to traditional eyelid surgery, known as blepharoplasty. It avoids burning and stitches, resulting in less bruising and a quicker recovery. Research indicates that this method not only shortens recovery time but also enhances the appearance of eyelids, providing a more youthful look. Surgeons find the procedure easy and efficient, leading to high satisfaction. Overall, Ziplyft effectively removes excess eyelid skin and may even improve side vision. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults aged 35 or older who have excess eyelid skin and are eligible for surgery can join this trial. They must be able to follow instructions, attend follow-up visits, and use contraception if of childbearing potential. Exclusions include prior eyelid surgeries, ptosis diagnosis, recent investigational study participation, tobacco use within 3 months, adhesive allergies, pregnancy/nursing status, certain medical conditions like Myasthenia Gravis or Graves' Disease.

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

Willing to return for required follow-up visits

Exclusion Criteria

I have had surgery in the eyelid or eyebrow area.

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

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of patient satisfaction, eyelid symmetry, and post-operative ecchymosis.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ziplyft

Trial Overview The trial is testing Ziplyft™ in eyelid surgery patients to assess outcomes reported by both the patient and surgeon. It will also evaluate bruising levels, symmetry of results, effectiveness of tissue adhesive for wound closure compared to traditional methods and overall time taken per case.

How Is the Trial Designed?

Group I: Ziplyft Device Experimental Treatment 1 Intervention

Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin.

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. optometrytimes.com optometrytimes.com/view/ascrs-2025-a-noninvasive-approach-to-blepharoplasty-reduces-recovery-time-bruising

ASCRS 2025: A noninvasive approach to blepharoplasty ... Ziplyft offers a minimally invasive alternative to traditional blepharoplasty—no cautery, no sutures, less bruising. Faster procedure time ( ...

3. ziplyft.com ziplyft.com/

Ziplyft: OSHERU This procedure restores peripheral vision and creates a younger more revitalized appearance by removing excess skin from the upper lid.

4. 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 ...

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

Ziplyft for Eyelid Surgery The objective of this study is to evaluate patient-reported outcomes, surgeon reported outcomes, bruising, symmetry, the success of tissue adhesive for wound ...

6. glance.eyesoneyecare.com glance.eyesoneyecare.com/stories/2024-07-26/osheru-raises-usd4-7m-to-advance-blepharoplasty-surgical-device/

Osheru raises $4.7M to advance blepharoplasty surgical ... Ziplyft is a patented, FDA Class 1 medical device designed to—essentially—make eyelid surgery easier for both the patient and surgeon. Notable ...

7. ziplyft.com ziplyft.com/about-us/

About Us - Ziplyft The Ziplyft offers a safer, faster, and more effective solution for eyelid surgery for patients and surgeons alike, ensuring a more youthful, revitalized ...