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| Name | Class |
|---|---|
| Manchester Royal Eye Hospital | OTHER |
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The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.
Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UNITY VCS | Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) |
| |
| CONSTELLATION | Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNITY VCS | Device | UNITY® VCS is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)? | Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient. | Up to Day 1 post completion of the surgery |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Subjects will be recruited from the clinical practice of the participating Investigator.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alcon Call Center | Contact | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Name | Affiliation | Role |
|---|---|---|
| Manager, Health Economics/Outcomes Research | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Royal Eye Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D014823 | Vitreous Hemorrhage |
| D012163 | Retinal Detachment |
| D019773 | Epiretinal Membrane |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D005130 | Eye Hemorrhage |
| D006470 | Hemorrhage |
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| CONSTELLATION | Device | CONSTELLATION is a CE-marked, FDA-approved ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The focus of this study will be on combined anterior-posterior segments surgery (phacovitrectomy). |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |