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| Name | Class |
|---|---|
| Clinique Monchoisi | UNKNOWN |
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Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish® | Device | Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of DSCI on IOP fluctuation profile as recorded by Triggerfish® in patients with POAG. | The IOP fluctuation profile will be recorded by Triggerfish® in patients with POAG
| 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of DSCI on the diurnal and nocturnal IOP fluctuation pattern | Diurnal and nocturnal IOP fluctuation pattern, wake/sleep and sleep/wake Triggerfish® slopes, Timing of Triggerfish® acrophase, Concomitant IOP-lowering topical drug use | 3 months |
| Changes in visual field 3 months after DSCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André Mermoud, MD | Clinique Monchoisi, Unité du Glaucome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Monchoisi, Unité du Glaucome | Lausanne | 1006 | Switzerland |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Change in the visual field |
| 3 months |
| Safety and tolerability | Adverse events and serious adverse events collected throughout the duration of the study | 3 months |