Topcon 3D OCT-1000 Optical Coherence Tomography System

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

Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study

The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

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 York
      • Bronxville, New York, United States, 10708
        • Retina Consultations
      • New York, New York, United States, 10003
        • New York Eye and Ear-Glaucoma Associates of New York
      • New York, New York, United States, 10022
        • Vitreous-Retina-Macula Consultants of NY
      • New York, New York, United States, 10036
        • SUNY

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ophthalmology practice

Description

Retinal Disease Study

No Retinal Disease:

Inclusion Criteria:

  • Male or female
  • Between 18 and 80 years of age
  • Either eye, but only one eye per subject will be enrolled
  • Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

  • Any known ocular disease
  • Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc.
  • Topcon image quality factor ≤ 44 or Stratus signal strength < 5.

Retinal Disease

Inclusion Criteria:

  • Male or female
  • Between 18 and 80 years of age
  • Either eye, but only one eye per subject will be enrolled
  • Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study
  • A range of retinal thickness will be included
  • Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5.

Exclusion Criteria:

  • Presence of glaucoma
  • Topcon image quality factor ≤ 44 or Stratus signal strength < 5.

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
1
Patients with Retinal Disease
2
Patients without Retinal Disease
3
Normal Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device
Time Frame: 30 Minutes

The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement.

Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer
30 Minutes

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

October 1, 2008

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (ESTIMATE)

November 17, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Topcon 01

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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