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

NCT03439774 | Completed FDA Device

• 1 other identifier: Topcon-TON-US-0002
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Agreement of IOP

  Agreement of the measured IOP between the test devices and the predicate device for the tonometer function of CT-800 and TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and linear regression.

  1 day

• Agreement of Corneal Thickness

  Agreement of measured corneal thickness between the test device and the predicate device for the pachymeter function of the TRK-2P. Presentation of results and analyses will include descriptive statistics (mean, standard deviation, limits of agreement), Bland-Altman plot and Deming regression.

  1 day

Study Arms (1)

Adults 18 years old or older

Device: Topcon CT-800; Device: Topcon TRK-2P

Interventions

Topcon CT-800 DEVICE

tonometer

Adults 18 years old or older

Topcon TRK-2P DEVICE

tonometer, pachymeter

Adults 18 years old or older

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Approximately 250 subjects will have both of their eyes measured.

You may qualify if:

• be at least 18 years of age of either sex and any race or ethnicity;
• be willing and able to provide written informed consent prior to any study procedures being performed;
• be willing and able to follow all instructions and attend all study visits;

You may not qualify if:

• have only one functional eye;
• have poor or eccentric fixation in either eye;
• have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;
• have microphthalmos in either eye;
• have buphthalmos in either eye;
• be a 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;
• have dry eyes, meaning having been diagnosed by a physician with dry eyes and currently using a prescribed medication or daily use of an artificial tear;
• be a lid squeezer - blepharospasm;
• have nystagmus in either eye;
• have keratoconus in either eye;
• have any other corneal or conjunctival pathology or infection in either eye;
• have a 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.

Sponsors & Collaborators

• Topcon Medical Systems, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: February 20, 2018
• Study Start: May 5, 2017
• Primary Completion: April 17, 2018
• Study Completion: June 30, 2018
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

US (1)