Actively Recruiting
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
Led by Osheru Inc. · Updated on 2025-08-27
200
Participants Needed
5
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating Patient Reported Outcomes and Surgeon Satisfaction With Ziplyft™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, 63 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, including intrauterine, hormonal, barrier with spermicide, or abstinence.
You will not qualify if you...
- 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).
- Subjects that have had any previous surgery eyelid or eyebrow region.
- Use of anticoagulation therapy, including 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
- Allergy to adhesive glue
- 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.
- Pregnant or nursing females.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
Actively Recruiting
2
Vance Thompson Vision
Alexandria, Minnesota, United States, 56308
Actively Recruiting
3
Eye Care Specialists
Kingston, Pennsylvania, United States, 18704
Actively Recruiting
4
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
5
The Eye Centers of Racine and Kenosha, LTD
Kenosha, Wisconsin, United States, 53142
Actively Recruiting
Research Team
P
Patricia Buehler, MD
CONTACT
B
Becky Weathers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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