Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
Osheru Inc.
Summary
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.
Eligibility
- Age range
- 35+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceZiplyft
Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™.
Locations (5)
- Center for Excellence in Eye CareMiami, Florida
- Vance Thompson VisionAlexandria, Minnesota
- Eye Care SpecialistsKingston, Pennsylvania
- Vance Thompson VisionSioux Falls, South Dakota
- The Eye Centers of Racine and Kenosha, LTDKenosha, Wisconsin