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
Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 15 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker.
Only one eye per subject can be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitreoretinal surgery supported by Luca System | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitreoretinal surgery | Device | Patients undergoing vitreoretinal surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | incidence and severity of investigational device-related (definitely or probably) adverse events, for all subjects treated with the study device (Safety Population). | 3 Months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlene Braun | Contact | +33663334352 | charlene.braun@acusurgical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Recruiting | Ghent | East Flanders | 9000 | Belgium |
Not provided
| ID | Term |
|---|---|
| D057586 | Vitreoretinal Surgery |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided