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)

Topcon Medical Systems, Inc.1 site in 1 country65 target enrollmentApril 2014

ConditionsIntraocular Pressure Corneal Pachymetry

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intraocular Pressure
Sponsor: Topcon Medical Systems, Inc.
Enrollment: 65
Locations: 1
Primary Endpoint: Agreement of intraocular pressure measurements from predicate vs. investigational device
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

December 2014

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Topcon Medical Systems, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age of either sex and any race or ethnicity;
•Willing and able to provide written informed consent prior to any study procedures being performed;
•Willing and able to follow all instructions and attend all study visits;
•Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion Criteria

•Only one functional eye;
•Poor or eccentric fixation;
•Corneal scarring or have had corneal surgery, including corneal laser surgery;
•Microphthalmos;
•Buphthalmos;
•Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
•Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
•Lid squeezer - blepharospasm;
•Nystagmus;
•Keratoconus;