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The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.
60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study device during 3 hours | Experimental |
| |
| Study device during 6 hours | Experimental |
| |
| Study device during 9 hours | Experimental |
| |
| Study device during 12 hours | Experimental |
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| Study device during 15 hours | Experimental |
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| Study device during 18 hours | Experimental |
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| Study device during 21 hours | Experimental |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSIMED Triggerfish | Device | Soft contact lens-based device for the continuous monitoring of IOP fluctuations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between study device signal and tonometer reading | during 24 hours of study device wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milko Iliev, MD | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Leuven | 3000 | Belgium | |||
| University Hospital Glostrup |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Study device during 24 hours |
| Experimental |
|
| Tonometric assessment during 24 hours | Active Comparator |
|
| Tonometer | Device | Tonometric assessment of IOP |
|
| Glostrup Municipality |
| 2600 |
| Denmark |
| Hospital ClĂnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitari i Politècnic la Fe | Valencia | 46026 | Spain |
| Inselspital | Bern | 3010 | Switzerland |