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

Intraocular Pressure Clinical Trial

Official title:

Comparative Study of the Topcon Tonometers CT-800 and TRK-2P and the Haag-Streit Goldmann Manual Tonometer (Predicate) to Demonstrate Conformance 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 and Comparison of Pachymetry Values for Topcon TRK-2P With the Topcon SP-1P (Predicate)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439774
• Other study ID #: Topcon-TON-US-0002
• Status: Completed
• Start date: May 5, 2017
• Est. completion date: June 30, 2018

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: June 30, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be at least 18 years of age of either sex and any race or ethnicity;

2. be willing and able to provide written informed consent prior to any study procedures being performed;

3. be willing and able to follow all instructions and attend all study visits;

Exclusion Criteria:

1. have only one functional eye;

2. have poor or eccentric fixation in either eye;

3. have corneal scarring or have had corneal surgery, including corneal laser surgery in either eye;

4. have microphthalmos in either eye;

5. have buphthalmos in either eye;

6. 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;

7. 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;

8. be a lid squeezer - blepharospasm;

9. have nystagmus in either eye;

10. have keratoconus in either eye;

11. have any other corneal or conjunctival pathology or infection in either eye;

12. 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.

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Device:
• Topcon CT-800
tonometer
• Topcon TRK-2P
tonometer, pachymeter

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 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
Primary	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