Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™

Osheru Inc.200 enrolled

Overview

The objective of this study is to evaluate patient-reported outcomes, surgeon reported outcomes, bruising, symmetry, the success of tissue adhesive for wound closure, and case time.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Blepharoplasty

Interventions

ZiplyftDEVICE

Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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 4. Willing to return for required follow-up visits. 5. Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator. 6. 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.

Locations (5)

Center for Excellence in Eye Care

Miami, Florida, United States

RECRUITING

Vance Thompson Vision

Alexandria, Minnesota, United States

RECRUITING

Eye Care Specialists

Kingston, Pennsylvania, United States

Outcomes

Primary Outcomes

Improvement in overall patient satisfaction - Satisfaction with facial appearance and eyes

Demonstrate an improvement in overall patient satisfaction by comparing pre-operative and post-operative patient reported outcome scores. FACE-Q - Aesthetics - Appearance - Satisfaction with facial appearance FACE-Q - Aesthetics - Appearance - Satisfaction with Eyes On a scale of 1-4 Very Dissatisfied being 1 and Very Satisfied being 4

Time frame: From enrollment to the last visit at 3 months

Surgeon Satisfaction and Efficiency

Demonstrate surgeon satisfaction and efficiency with Ziplyft™, measured by Surgeon Satisfaction Survey with questions focused on ease of procedure, patient tolerance, device useability, surgical technique, procedural time, wound closure, need for suture, ease of achieving symmetry, device placement on the lid crease, cutting mechanism, seal of the zipper-locked tissue, surgical time and evaluating for post-operative complications with 5 being better outcome and 1 being worse.

Time frame: From enrollment to the last visit at 3 months.

Improvement in Eye Age

Demonstrate improvement in Eye Age and Face Age after the Ziplyft™ procedure. FACE-Q - Aesthetics - Appearance - Aging Appraisal On a scale of 1-4, with 1 being Definitely Disagree and 4 being Definitely agree

Time frame: From enrollment to the last visit at 3 months.

Measure the success of tissue adhesive for wound closure.

Measuring the success of the tissue adhesive involves evaluating the following: Visual inspection, Adhesion strength and adherence, and Patient satisfaction. Questions added in the patient satisfaction survey about comfort of glue, ease of blinking, aesthetically acceptable with 1 being a worse outcome and 4 being better.

Time frame: From enrollment to the last visit at 3 months.

Post-operative ecchymosis

Document post-operative ecchymosis with Ziplyft. Measured by post-operative photographs.

Central Contacts

Patricia Buehler, MD

CONTACT

541-419-4412 pbuehler@osheru.com

Becky Weathers

CONTACT

541-312-4622 bweathers@osheru.com

Data from ClinicalTrials.gov

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