An interventional study of CATS tonometer prism and Goldmann Tonometer prism in Ocular Hypotension, 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 2018-10-22.
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). 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.
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.
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
Device: Goldmann Tonometer prism
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
Device: CATS tonometer prism
IOP tonometer prism for assessment of intraocular pressure
IOP tonometer prism for assessment of intraocular pressure
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings.
Time frame: 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.
Time frame: From date of randomization until 24 hours
Plan to share: No
Ran from Jan 2017 to primary completion in Oct 2018, 21 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Ocular Hypotension
Intuor Technologies, Inc.