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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziplyft Device | Experimental | Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziplyft | Device | Ziplyft™ is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin using a novel surgical device called Ziplyft™. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | From enrollment to the last visit at 3 months. |
| Post-operative ecchymosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Buehler, MD | Contact | 541-419-4412 | pbuehler@osheru.com | |
| Becky Weathers | Contact | 541-312-4622 | bweathers@osheru.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Excellence in Eye Care | Recruiting | Miami | Florida | 33176 | United States |
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Document post-operative ecchymosis with Ziplyft. Measured by post-operative photographs.
| From enrollment to the last visit at 3 months. |
| Eyelid Symmetry | To achieve optimal eyelid symmetry after eyelid surgery with Ziplyft™ by independent reviewers' assessments. Measurement of symmetry will be judged on a scale of 1-4 by an independent reviewer based on post-op patient photos. 1 being worse and 4 being better outcome. | From enrollment to the last visit at 3 months. |
| Improved case time | Demonstrate improved case time with Ziplyft™ | From enrollment to last visit at 3 months. |
| Vance Thompson Vision | Recruiting | Alexandria | Minnesota | 56308 | United States |
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| Eye Care Specialists | Recruiting | Kingston | Pennsylvania | 18704 | United States |
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| Vance Thompson Vision | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
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| The Eye Centers of Racine and Kenosha, LTD | Recruiting | Kenosha | Wisconsin | 53142 | United States |
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