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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
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This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.
The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SENSIMED Triggerfish | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish | Device | Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acquisition of 24-hour Sensor output signal | Performance is assessed as the portion of valid data (actual number of valid data points recorded compared to expected number of recorded data points) during 24-hour recording. | After 24-hour continuous recording |
| Measure | Description | Time Frame |
|---|---|---|
| Possible IOP fluctuation | Fluctuation is defined as a change of 25% or more from the mean Sensor output over 24 hours for each participant. | After 24-hour recording with study device |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Geneva | Geneva | 1211 | Switzerland |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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