Agreement and Precision Study

January 31, 2025 updated by: Topcon Corporation

TRK-3 Agreement and Precision of Pachymetry Function

To evaluate the performance of pachymetry function

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects seeing an eye doctor that have normal cornea, cornea abnormality, or glaucoma

Description

Inclusion Criteria:

  • Provide voluntary written consent
  • Age at least 22 years old
  • For glaucoma group only, visual field defect and optic nerve damage consistent with glaucoma
  • For cornea group only, cornea abnormality

Exclusion Criteria:

  • Ocular condition that may affect ability to perform cornea measurements
  • Have or is suspected to have ocular infection
  • Unable to tolerate eye testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
Subjects with healthy cornea
Device: Pachymeter
Measure the thickness of the cornea
Other Names:
  • TRK-3 auto kerato-refracto tonometer
Cornea
Subjects with abnormal cornea
Device: Pachymeter
Measure the thickness of the cornea
Other Names:
  • TRK-3 auto kerato-refracto tonometer
Glaucoma
Subjects with glaucoma
Device: Pachymeter
Measure the thickness of the cornea
Other Names:
  • TRK-3 auto kerato-refracto tonometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cornea thickness
Time Frame: 1 day
thickness of the cornea
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2025

Primary Completion (Actual)

January 28, 2025

Study Completion (Actual)

January 28, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THQ-THINC-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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