NCT02138279

Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 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 CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Topcon Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.

Conditions

• Intraocular Pressure
• Corneal Pachymetry

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2014-05-14
• Last updated: 2022-06-08

Locations

1 site across 1 country: United States