An interventional study of CATS tonometer prism and Goldmann tonometer prism in Ocular Hypertension, sponsored by Intuor Technologies, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Intuor Technologies, Inc. · Not applicable, Interventional, and Diagnostic
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.
659 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's enrollment of 86 is below the median of 114 across 520 interventional studies indexed under Ocular Hypertension.
Browse Ocular Hypertension studies →Intuor Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism
Device: Goldmann tonometer prism
CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism
Device: CATS tonometer prism
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
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
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
Time frame: From date of randomization until 24 hours
Plan to share: No
Ran from Jan 2017 to primary completion in Nov 2017, 10 months.
Of 47 interventional studies with no phase under Ocular Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Intuor Technologies, Inc.