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Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCare IC1000 vs GAT, iCare IC200 and Perkins | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCare IC1000 | Device | Measurement of Intraocular Pressure (IOP) in sitting and supine position |
|
| 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 the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups. | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective analysis of "Quick Measure" mode | The secondary objective of this study is to do a retrospective analysis of "Quick Measure" mode. Instead of 6 shots that are taken in Default Measure, Quick Measure takes only 2 shots (or 3 shots if the difference between the first two shots is greater than 2 mmHg). The Quick Measure results are calculated retrospectively from the raw data of the Default Measure results. Quick Measure comparison to reference measurements is done similarly as with Default Measure. |
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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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| iCare IC200 | Device | Measurement of Intraocular Pressure (IOP) in sitting and supine position |
|
| GAT | Device | Measurement of Intraocular Pressure (IOP) in sitting position |
|
| Perkins | Device | Measurement of Intraocular Pressure (IOP) in supine position |
|
| Through study completion, an average of 6 months |