Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorOsheru Inc.
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Subjects with a current Ptosis diagnosis
Subjects with a history of Graves' Disease
Subjects with Myasthenia Gravis
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).
Trial design
Treatments tested in this trial
- Ziplyft Device
- Comparator Arm: Standard Blepharoplasty
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov