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

Intraocular Pressure Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138279
• Other study ID #: TOPCON-TON-US-0001
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2022
• Source: Topcon Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Pachymetry
• Intraocular Pressure

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Topcon Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of intraocular pressure measurements from predicate vs. investigational device		Single timepoint - 1 day
Primary	Agreement of central corneal thickness measurements from predicate vs. investigational device		Single time point - 1 day