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Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCare ST500 vs GAT and iCare IC200 | Experimental | Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCare ST500 | Device | Measurement of Intraocular Pressure (IOP) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers | Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups. | Through study completion, an average of 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nova Scotia Health/Dalhousie University | Halifax | Nova Scotia | B3H 2Y9 | Canada |
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Investigator cannot see the measurement results.
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| GAT |
| Device |
Measurement of Intraocular Pressure (IOP) |
|
| iCare IC200 | Device | Measurement of Intraocular Pressure (IOP) |
|