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Clinical trial

Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 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 and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)

NCT02138279 is registered in ClinicalTrials.gov with Topcon Medical Systems, Inc. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 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 and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
Lead sponsor
Topcon Medical Systems, Inc.
Phase
Observational
Overall status
Completed
Start date
April 30, 2014
Completion date
December 31, 2014
Enrollment
65 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

corneal pachymetry, intraocular pressure