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Sponsor's business decision based on strategic shifts
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This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Vitreoretinal ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) |
|
| CONSTELLATION Vision System | Active Comparator | Vitreoretinal ophthalmic surgery in one eye using CONSTELLATION Vision System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Device | UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vitreoretinal surgeries performed using 27-gauge consumables | The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery | Day 0 operative |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Surgical | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Macula Institute of Arizona | Scottsdale | Arizona | 85255 | United States | ||
| Retina Associates of Orange County |
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|
| CONSTELLATION Vision System | Device | CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. |
|
| Vitreoretinal ophthalmic surgery | Procedure | Ophthalmic surgery performed in the posterior segment of the eye |
|
| Laguna Hills |
| California |
| 92653 |
| United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Vision Research Center Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| NYC Retina - Manhattan | New York | New York | 10003 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D005130 | Eye Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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