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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439774
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Topcon Corporation ( Topcon Medical Systems, Inc. )

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 : April 17, 2018
Actual Study Completion Date : June 30, 2018
Arms and Interventions
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Arm Intervention/treatment
Adults 18 years old or older Device: Topcon CT-800
tonometer

Device: Topcon TRK-2P
tonometer, pachymeter


Outcome Measures
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Primary Outcome Measures :
  1. Agreement of IOP [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439774


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Topcon Medical Systems, Inc.
More Information
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT03439774    
Other Study ID Numbers: Topcon-TON-US-0002
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes