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Clinical trial

Comparative Study of the NIDEK TONOREF III 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 NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)

NCT03441477 is registered in ClinicalTrials.gov with Nidek Co. LTD. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
Comparative Study of the NIDEK TONOREF III 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 NIDEK TONOREF III With the NIDEK CEM-530 (Predicate)
Lead sponsor
Nidek Co. LTD.
Phase
Not reported
Overall status
Completed
Start date
December 17, 2017
Completion date
January 16, 2019
Enrollment
225 (actual)
Sites
1

Conditions

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

intraocular pressure