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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). Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based on standard of care vision examination at the clinical investigation sites. All subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted. The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goldmann Tonometer | Active Comparator | determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism |
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| CATS tonometer | Active Comparator | determine if the CATS tonometer prism effectively reduces sensitivity to IOP errors produced by corneal thickness and therefore provides a more accurate IOP reading compared to the reference tonometer (Goldmann prism), based upon the correction value table for Goldmann tonometer prism |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CATS tonometer prism | Device | IOP tonometer prism for assessment of intraocular pressure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings. | From date of randomization until 24 hours | |
| All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table. | 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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| ID | Term |
|---|---|
| D015814 | Ocular Hypotension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Goldmann Tonometer prism |
| Device |
IOP tonometer prism for assessment of intraocular pressure |
|