Clinical Study of the Topcon Pachymeter TRK-3 to Evaluate Agreement and Precision

July 19, 2022 updated by: Topcon Corporation
Agreement and Precision of corneal thickness measurement (pachymetry) function of the test device TRK-3 and the predicate device SP-1P will be evaluated in volunteers, and safety will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

  • Japan
      • Tokyo, Japan
        • Samoncho Clinic

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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing pachymetry measurement

Description

Inclusion Criteria:

  1. Individuals who gave written informed consent to participate in the clinical trial by their free will.
  2. Individuals who aged 20 years or older at the time of informed consent
  3. Individuals who were deemed eligible for the study by the investigator for screening prior to enrollment.
  4. Subjects who are able to comply with compliance items during participation in the clinical trial, undergo medical examination and examination specified in the protocol, and report subjective symptoms, etc.

Exclusion Criteria:

  1. Individuals with ocular diseases that may affect corneal thickness measurement (blindness, corneal perforation, bullous keratopathy, nystagmus, etc.) or who have a history of ocular diseases and are considered by the investigator to be ineligible for participation in the study.
  2. Individuals who have or are suspected of suffering from ocular or systemic infections.
  3. Other persons who are judged by the investigator to be unfavorable candidates for the study.

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
Adults 20 years old or older
Device: SP-1P
A subject undergoes corneal thickness measurement with pachymeter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal thickness
Time Frame: 1 day
Corneal thickness
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)

November 27, 2021

Primary Completion (ACTUAL)

November 27, 2021

Study Completion (ACTUAL)

November 27, 2021

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (ACTUAL)

March 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • THQ-2021-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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