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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Ziplyft Device
DeviceZiplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Ziplyft compresses the excess skin and seals it together, no suturing is required, and the surgery incision will be closed with tissue adhesive.
Comparator Arm: Standard Blepharoplasty
Other interventionStandard blepharoplasty will be used on the fellow side of the participant's face. Standard blepharoplasty uses a blade, cautery to seal blood vessels, and sutures to close the incision.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Comparing Ziplyft Device Treatment to Standard BlepharoplastyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
The surgeon will record the surgical case times for Ziplyft and standard blepharoplasty. For the Ziplyft side of the participant's face the surgical case time begins when the Ziplyft device touches the patient lid and ends 1 min after adhesive is applied as that is when it has cured. For the standard blepharoplasty side of the participant's face the surgical case time begins as the blade begins its first cut and ends once ointment has been applied.
Time frame
From the beginning of the surgical case until surgery has been completed2
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
Ecchymosis will be measured by post-operative photographs taken at day 3 and day 7. Photos will be rated on a 1-4 scale for ecchymosis by an independent masked observer (physician).
Time frame
3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)3
Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.
Photos taken at 9 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by an independent masked observer (physician).
Time frame
9 days (± 3 days) to up to 2 months (± 1 month) post-operation4
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
Patient satisfaction questionnaires regarding comfort, satisfaction, and healing experience will be administered to the participants on the day of surgery and at 2 months post operation.
Time frame
After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operationSponsors and contacts
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Source ClinicalTrials.gov