NCT03439774

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 345 (actual)
• Sponsor: Topcon Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Topcon CT-800	tonometer
DEVICE	Topcon TRK-2P	tonometer, pachymeter

Timeline

• Start date: 2017-05-05
• Primary completion: 2018-04-17
• Completion: 2018-06-30
• First posted: 2018-02-20
• Last updated: 2022-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study