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In this study, the investigators want to investigate the success of aqueous humor shunting in the retrobulbar space, using the eyeTube in combination with the eyeWatch implant. The investigators postulate that posterior aqueous humor shunting would be more effective, as this space offers a larger drainage area and a less aggressive local inflammatory environment than the subconjunctival space close to the limbus, resulting in lower and better-sustained IOP than in the more limited, fibroblast-promoting subconjunctival environment surrounding standard implants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated with the eyeTube | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eyeTube | Device | Implantation of a drainage device in the eye, in combination with the eyeWatch implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) reduction | The proportion of subjects achieving a mean reduction in IOP of ≥ 20% compared with pre-operative pressure at 12 months with the same or fewer hypotensive drugs. | 12 months |
| Adverse events | The incidence and severity of adverse events in the study eye (overall and related to the eyeWatch system) throughout the follow-up period. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senghor Centre | Mbour | Senegal |
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