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because a device deficiency that occured in the Iris vitrectomy system (Alfa version)
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To perform a safety study on the prototype IRIS vitrectomy device.
to determine the safety and effectiveness of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRIS vitrectomy device | Experimental | all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRIS | Device | prototype IRIS vitrectomy device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of intra-operative adverse events that determine the safety of the surgery | complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem | Intraoperative (surgery day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, PHd MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Vlaams Brabant | 3020 | Belgium |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2023 | |
| Reset | Jan 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2023 | Jan 3, 2024 |
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