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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)
Conditions
Interventions
Topcon CT-800
Topcon TRK-2P
Locations
1
United States
Andover Eye Associates
Andover, Massachusetts, United States
Start Date
May 5, 2017
Primary Completion Date
April 17, 2018
Completion Date
June 30, 2018
Last Updated
June 8, 2022
NCT04281017
NCT06275308
NCT06689696
NCT07073937
NCT05850936
NCT07424417
Lead Sponsor
Topcon Medical Systems, Inc.
Data Source & Attribution
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