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The aim of this clinical study is to provide information about the variability of the intraocular pressure (IOP) self-measurements with the iCare HOME2 tonometer in comparison to the variability of the IOP measurements with the reference tonometer (iCare IC200), over a wide range of IOP values.
The clinical study is planned to estimate the variability of the IOP measurement of iCare HOME2 and IC200. In the study, the subjects will learn to operate the iCare HOME2 tonometer independently by using the labeling materials provided to them. Once they learn to operate the tonometer, subjects will take three self-measurements on the selected eye both in sitting and supine position.
The variability of the measurement results taken with iCare HOME2 will be compared to the variability of the measurement results taken with iCare IC200 by using the recorded results from the study subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iCare HOME2 vs iCare IC200 | Experimental | Measurement of intraocular pressure (IOP) with iCare IC200 reference tonometer compared to iCare HOME2 test tonometer. Measurement will be performed to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCare HOME2 vs iCare IC200 | Device | Measurement of IOP with iCare HOME2 compared with iCare IC200. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of IOP measurements | Repeatability of IOP measurements comparison of iCare HOME2 vs iCare IC200 | Through study completion, an average of 1-2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle A Sato, MD | East West Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East West Eye Institute | Los Angeles | California | 90013 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Investigator cannot see both the test device and reference device measurement results.
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