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The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults 18 years old or older | Experimental | NIDEK TONOREFIII |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIDEK TONOREF III | Device | The auto ref/kerato/tono/pachymeter TONOREF III is a medical device which measures objective refractive errors, corneal curvature radius, intraocular pressure and corneal thickness of the patient's eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalent to legally-marketed devices | Agreement of intraocular pressure (mmHg) measurement for TONOREFIII and PAT | One or two study visits per subject. One visit is less than two hours. |
| Equivalent to the pachymeter function | Agreement of central corneal thickness (µm) measurement for TONOREF III and CEM-530 | One or two study visits per subject. One visit is less than two hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The numbers of adverse events | To demonstrate that the test device is as safe as the predicate devices. | One or two study visits per subject. One visit is less than two hours. |
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Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Tadakazu Ichimura | Nidek Co. LTD. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aston University | Birmingham | Birmingham | B4 7ET, UK | United Kingdom |
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| Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER | Device | Haag-Streit Goldmann Manual Tonometer measures intraocular pressure to aid in the screening and diagnosis of glaucoma |
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| NIDEK CEM-530 | Device | Nidek CEM-530 is a non-contact ophthalmic microscope, optical pachymeter, and camera used for examination of the corneal endothelium and for measurement of the thickness of the cornea. |
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