An observational study in Intraocular Pressure, sponsored by Topcon Medical Systems, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by Topcon Medical Systems, Inc. (part of Topcon Corporation) · Observational
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The study will assess the CT-800 and TRK-2P for conformity to ANSI Z80.10-2014 Ophthalmic Instruments - Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the applicable Supplemental Information Sheet. This clinical device study will also assess the substantial equivalence of TRK-2P to a predicate device in regard to pachymetry.
Topcon Medical Systems, Inc. is the lead sponsor of 26 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 250 subjects will have both of their eyes measured.
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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.
Device: Topcon CT-800 · Device: Topcon TRK-2P
tonometer
tonometer, pachymeter
Agreement of IOP
Agreement of the measured IOP between the test devices and the predicate device for the tonometer function of CT-800 and TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and linear regression.
Time frame: 1 day
Agreement of Corneal Thickness
Agreement of measured corneal thickness between the test device and the predicate device for the pachymeter function of the TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and Deming regression.
Time frame: 1 day
Ran from May 2017 to primary completion in Apr 2018, 11 months.
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Topcon Medical Systems, Inc. →