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| Name | Class |
|---|---|
| CBCC Global Research | NETWORK |
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This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 27 GA Vista Ophthalmics vitrector | Experimental | The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vista Vitrectomy Probe | Device | Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative rates of retinal tears | Calculate the incidence of post-operative rates of retinal tears | Month 1 |
| Incidence of retinal detachment | Calculate the incidence of post-operative retinal detachment | Month 1 |
| Incidence of sclerotomy complications like leakage | Calculate the incidence of post-operative sclerotomy complications like leakage | Month 1 |
| Incidence of ocular hypotony | Calculate the incidence of post-operative ocular hypotony | Month 1 |
| Incidence of choroidal detachment | Calculate the incidence of post-operative choroidal detachment | Month 1 |
| Incidence of visually significant vitreous hemorrhage | Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse) | Month 1 |
| Incidence of endophthalmitis | Calculate the incidence of post-operative endophthalmitis | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon- will assess device adequacy for removal of vitreous | Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages | Day 0 (Operative Visit) |
| Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Knowles | VISTA Ophthalmics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CBCC Global Research Site:003 | Los Angeles | California | 90067 | United States | ||
| CBCC Global Research Site:002 |
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Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking, at any post-operative visit will be summarized using counts and percentages |
| Days1, 7, 30 & 90 |
| Bradenton |
| Florida |
| 34209 |
| United States |
| CBCC Global Research Site:001 | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| CBCC Global Research Site:004 | McAllen | Texas | 78503 | United States |