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This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCVB Implant | Experimental | All subjects in this study are in the experimental treatment arm and will receive the FCVB implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foldable Capsular Vitreous Body Implant | Device | Vitrectomy augmented with the implantation of the FCVB implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-ocular pressure | Evaluation of the device as long-term solution for maintenance the intra-ocular pressure, potentially reducing the number of surgeries (silicone oil exchanges) for the patient | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans, MD Phd | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven (UZLeuven) | Leuven | Vl-Brabant | B3000 | Belgium |
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