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Actively Recruiting

Phase Not Applicable
Age: 35Years +
All Genders
ID07250139

Comparison of Ziplyft Device and Traditional Surgery for Upper Eyelid Skin Removal Evaluating outcomes like bruising, wound healing, and surgery time

Led by Osheru Inc. · Updated on 2025-11-26

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two surgical methods for upper eyelid surgery called blepharoplasty, which removes excess skin that can affect peripheral vision and appearance. The study uses a split-face design where one eyelid undergoes traditional surgery using a blade, cautery, and sutures, while the other eyelid is treated with Ziplyft, a clamp device that compresses the skin to prevent bleeding and uses tissue adhesive instead of sutures. The goal is to evaluate bruising, wound healing, surgery time, and satisfaction from both patients and surgeons. Participants will have one eyelid treated with standard blepharoplasty involving blade removal, blood vessel cautery, and suturing, and the other eyelid treated with Ziplyft which compresses skin to stop bleeding, allowing incision closure with tissue adhesive. Both sides will have equal amounts of skin removed. The surgeon will record the time taken for each procedure. Follow-up photos will be taken at 3, 7 days, and 1 month after surgery to assess bruising and incision healing. During the study, participants will be evaluated with independent professional review of post-operative photos to measure bruising and incision appearance. Both patient and surgeon surveys will capture satisfaction levels up to two months after surgery. The study tracks wound closure success and compares surgical case times. Follow-up visits and evaluations will ensure comprehensive monitoring of outcomes and participant experience.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide signed written consent before any study procedures.
  • Ability and willingness to follow study instructions and complete all visits.
  • Male or female adults aged 35 years or older at preoperative visit.
  • Excess eyelid skin suitable for surgery as determined by the investigator.
  • Female participants must be 1-year postmenopausal, surgically sterilized, or have a negative pregnancy test if of childbearing potential.
  • Women of childbearing potential must use acceptable contraception throughout the study.
Not Eligible

You will not qualify if you...

  • Current diagnosis of ptosis.
  • History of Graves' Disease.
  • Diagnosis of Myasthenia Gravis.
  • Anatomical issues preventing device use (e.g., heavy brow, severe eyelid hollowing, ocular trauma).
  • Previous eyelid or eyebrow surgery.
  • Use of anticoagulation therapy within specified days before surgery.
  • Active or recent tobacco use within 3 months.
  • Allergy to adhesive glue.
  • Participation in other investigational studies within 30 days before or during this study.
  • Pregnancy or nursing.

Research Team

P

Patricia Buehler, MD

B

Becky Weathers

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