TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

June 6, 2022 updated by: Topcon Medical Systems, Inc.
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Study Type

Observational

Enrollment (Actual)

10

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
    • New Jersey
      • Oakland, New Jersey, United States, 07436
        • Topcon Medical Systems Inc.

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with no known eye disease.

Description

Inclusion Criteria

  • Participants must be at least 18 years of age
  • Participants must be able to complete all testing (all OCT scans)
  • Participants must volunteer to be in the study and sign the consent form

Exclusion Criteria

  • Subject with history of ocular disease or ocular pathology

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
Subjects Presenting With Normal Eyes
Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device
Device: DRI OCT Triton plus
OCT Machine used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement Variability of Signal to Noise Ratio
Time Frame: 1 hour
1 hour

Collaborators and Investigators

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

Sponsor

Topcon Medical Systems, Inc.

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

January 1, 2017

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Topcon Triton 1222-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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