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)

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Corneal Pachymetry

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ophthalmology practice

Description

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;
• Any other corneal or conjunctival pathology or infection;
• Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Male and female adults 18+ years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Agreement of intraocular pressure measurements from predicate vs. investigational device	Single timepoint - 1 day
Agreement of central corneal thickness measurements from predicate vs. investigational device	Single time point - 1 day

Collaborators and Investigators

• Sponsor: Topcon Medical Systems, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: May 12, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TOPCON-TON-US-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No