Recruiting
Not applicable
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
Condition(s) studied
Dermatochalasis of Upper EyelidPtosis, EyelidBlepharoplasty
Investigational drug(s) / intervention(s)
Ziplyft DeviceComparator Arm: Standard Blepharoplasty
Ziplyft Device: Ziplyft 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: Standard 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.
Study 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.
Eligibility
Inclusion Criteria:
1. Provide signed written consent prior to participation in any study-related procedures.
2. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
3. Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
4. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
5. 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:
1. Subjects with a current Ptosis diagnosis
2. Subjects with a history of Graves' Disease
3. Subjects with Myasthenia Gravis
4. 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).
5. Subjects that have had any previous surgery eyelid or eyebrow region.
6. 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.
7. Active or recent (within 3 months) tobacco user
8. Allergy to adhesive glue
9. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
10. Pregnant or nursing females.
Primary outcome measure(s)
- Compare surgical case time for Ziplyft treatment versus standard blepharoplasty — From the beginning of the surgical case until surgery has been completed
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.
- Document post-operative ecchymosis with Ziplyft and standard blepharoplasty — 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)
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).
- Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance. — 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
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).
- Assess patient reported outcomes with Ziplyft versus standard blepharoplasty — After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
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.
- Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty — The day of surgery until 2 months (± 1 month) post-operation
A surgeon-reported questionnaire regarding the procedure efficiency, bleeding, and the use of cautery and suture will be administered following the surgical procedure. A second surgeon-reported questionnaire regarding the use of adhesive, bruising, swelling, scaring, and symmetry will be administered at 2-months post operation.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| New Century Ophthalmology |
Oxford |
North Carolina |
Recruiting |
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