NW500 Non-Mydriatic Retinal Camera Clinical Performance Study

June 6, 2022 updated by: Topcon Corporation
Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Healthcare Solutions

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

Non-Probability Sample

Study Population

Subjects 18 years old or older.

Description

Inclusion Criteria:

  • Subjects who are 18 years of age or older on the date of informed consent.
  • Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.

Exclusion Criteria:

  • Subjects who are unable to tolerate ophthalmic imaging.
  • Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
  • Subjects who cannot follow instructions to complete the required 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults 18 years old or older
Device: fundus photography
color fundus photography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fundus photo image quality
Time Frame: 1 day
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)

March 1, 2022

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • THS-TPCN-2022-001

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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