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Clinical trial

Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance 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 and Comparison of Pachymetry Values for Topcon TRK-2P With the Topcon SP-1P (Predicate)

NCT03439774 is registered in ClinicalTrials.gov with Topcon Medical Systems, Inc. as lead sponsor.

NCT NCT03439774
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Registry record

As filed in ClinicalTrials.gov.

Title
Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance 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 and Comparison of Pachymetry Values for Topcon TRK-2P With the Topcon SP-1P (Predicate)
Lead sponsor
Topcon Medical Systems, Inc.
Phase
Observational
Overall status
Completed
Start date
May 5, 2017
Completion date
June 30, 2018
Enrollment
345 (actual)
Sites
1

Conditions

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

intraocular pressure