Retinal Fundus Camera Evaluation

June 6, 2022 updated by: Topcon Medical Systems, Inc.

TRC-NW400 Retinal Fundus Camera Image Evaluation and Instrument Comparison Protocol

Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. While also comparing the images to other manufacturer's retinal cameras

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Normal subjects will be recruited from Topcon Medical Systems.

Description

Inclusion Criteria:

  • Subjects with no known ocular diseases

Exclusion Criteria:

  • Subjects with known ocular diseases

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Healthy Eyes
Willing and able subjects with normal and healthy eyes
Device: Topcon TRC-NW400
Retinal Fundus Camera
Device: TRC-NW8
Retinal Fundus Camera
Device: TRC-NW400
Retinal Fundus Camera
Device: Canon-CR2
Retinal Fundus Camera
Device: Zeiss Visucam PRO
Retinal Fundus Camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fundus Image Grading
Time Frame: 1 Hour
Determining the best display to reflect the real color of the retina
1 Hour

Collaborators and Investigators

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

Sponsor

Topcon Medical Systems, Inc.

Investigators

  • Principal Investigator: Danny Leung, Clinical Trial Manager

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

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimate)

November 18, 2014

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

Other Study ID Numbers

  • TOPCON-003-2014

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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