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

• Sponsor: Topcon Medical Systems, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03439774
• Collaborator: (none)
• Enrollment: 345
• Location: 1
• Actual Duration (Months): 13.8
• Patients Per Site Per Month: 24.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Pressure	Device: Topcon CT-800; Device: Topcon TRK-2P

Study Design

• Study Type: Observational
• Actual Enrollment: 345 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: May 5, 2017
• Actual Primary Completion Date: Apr 17, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Adults 18 years old or older	Device: Topcon CT-800; tonometer; Device: Topcon TRK-2P; tonometer, pachymeter

Outcome Measures

Primary Outcome Measures

1. Agreement of IOP [1 day]

   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.

2. Agreement of Corneal Thickness [1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Andover Eye Associates	Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Topcon Medical Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Topcon Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT03439774
• Other Study ID Numbers: Topcon-TON-US-0002
• First Posted: Feb 20, 2018
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Jun 8, 2022