Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VISTHESIA 1.5 | Ophtalmologic surgery supported by Visthesia OVD |
| |
| ProVisc | Ophtalmologic surgery supported by Provisc OVD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVD | Device | Intraocular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP | Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg | 6-hours post-operatively |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients in need of cataract surgery
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
Not provided
Not provided
Not provided
Not provided