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Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goldmann Tonometer | Active Comparator | Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism |
|
| CATS tonometer | Experimental | CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CATS tonometer prism | Device | demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range |
| Measure | Description | Time Frame |
|---|---|---|
| All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness. | From date of randomization until 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Consultants | Tucson | Arizona | 85710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30796054 | Derived | McCafferty SJ, Tetrault K, McColgin A, Chue W, Levine J, Muller M. Modified Goldmann prism intraocular pressure measurement accuracy and correlation to corneal biomechanical metrics: multicentre randomised clinical trial. Br J Ophthalmol. 2019 Dec;103(12):1840-1844. doi: 10.1136/bjophthalmol-2018-313470. Epub 2019 Feb 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 6, 2019 | |
| Reset | Aug 23, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 6, 2019 | Aug 23, 2019 |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Goldmann tonometer prism | Device | demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range |
|