Comparative Study of the Topcon Tonometers CT-800 and TRK... | NCT03439774

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

NCT03439774

Sponsor

Topcon Medical Systems, Inc.

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

345Actual

Phase

Not provided

Conditions

Intraocular Pressure

Interventions

Topcon CT-800
Topcon TRK-2P

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 5, 2017Actual

Primary Completion Date

Apr 17, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Dec 8, 2017

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

345Actual

Label	Type	Description	Intervention Names
Adults 18 years old or older			Device: Topcon CT-800 Device: Topcon TRK-2P

Name	Type	Description	Arm Group Labels	Other Names
Topcon CT-800	Device	tonometer	Adults 18 years old or older
Topcon TRK-2P

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Approximately 250 subjects will have both of their eyes measured.

Sampling Method

Probability Sample