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Sponsor's business decision based on strategic shifts
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The purpose of the study is to compare the efficiency and safety of UNITY™ Vitreoretinal Cataract System (UNITY VCS) to CENTURION® Vision System with Active Sentry (CAS) in adult subjects with grade 2 or greater nuclear sclerotic cataracts who require phacoemulsification in both eyes. Subjects will attend a total of 8 scheduled visits for an individual duration of participation of approximately 1 month.
In this contralateral eye clinical study, one eye will undergo surgery with UNITY VCS and the other eye will undergo surgery with CAS. The second eye surgery will occur 0 to 14 days after the first eye surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNITY Vitreoretinal Cataract System (VCS) | Experimental | Anterior segment ophthalmic surgery in one eye using UNITY Vitreoretinal Cataract System (VCS) |
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| CENTURION Vision System with Active Sentry (CAS) | Active Comparator | Anterior segment ophthalmic surgery in one eye using CENTURION Vision System with Active Sentry (CAS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNITY Vitreoretinal Cataract System | 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. It consists of a console, remote control, foot controller, video overlay, and compatible anterior segment devices. In this study, it will be used for the removal of cataracts. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | Cumulative Dissipated Energy (CDE) is the measure of energy released at the level of the corneal incision during cataract surgery. CDE will be recorded by the system. | Day 0 surgery, each eye |
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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 |
|---|---|---|---|---|---|---|
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States | ||
| Vance Thompson Vision |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| CENTURION Vision System with Active Sentry | Device | CAS is a commercially approved surgical system for use during anterior segment ophthalmic surgery. It consists of a console, foot controller, remote control, video overlay, and compatible anterior segment devices. The Active Sentry handpiece will be used. |
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| Anterior segment ophthalmic surgery | Procedure | Cataract surgery during which the crystalline lens (often cloudy) is broken into small pieces and gently removed from the eye with suction (phacoemulsification) |
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| Sioux Falls |
| South Dakota |
| 57108 |
| United States |
| Whitsett Vision Group | Spring | Texas | 77388 | United States |
| Berkeley Eye Center | Sugar Land | Texas | 77478 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |