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Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer and Topcon SP-1P

NCT03439774 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 345

Last updated 2022-06-08

No results posted yet for this study

Summary

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.

Conditions

  • Intraocular Pressure

Interventions

DEVICE

Topcon CT-800

tonometer

DEVICE

Topcon TRK-2P

tonometer, pachymeter

Sponsors & Collaborators

  • Topcon Medical Systems, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-05
Primary Completion
2018-04-17
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439774 on ClinicalTrials.gov