Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation (NCT07250139) | Clinical Trial Compass
RecruitingNot Applicable
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
United States50 participantsStarted 2025-12-08
Plain-language summary
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.
Who can participate
Age range35 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Exclusion criteria
✕. Subjects with a current Ptosis diagnosis
✕. Subjects with a history of Graves' Disease
What they're measuring
1
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
Timeframe: From the beginning of the surgical case until surgery has been completed
2
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
Timeframe: 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.
Timeframe: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
4
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
Timeframe: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
5
Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty
Timeframe: The day of surgery until 2 months (± 1 month) post-operation
✕. 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).
✕. Subjects that have had any previous surgery eyelid or eyebrow region.
✕. Use of anticoagulation therapy, including, but not limited to Aspirin, NSAIDS, Ibuprofen within 7 days and Xarelto, Warfarin, Enoxaparin, Plavix within 3 days prior to planned study procedure.
✕. Active or recent (within 3 months) tobacco user