OCT Image Quality Performance Evaluation

December 10, 2021 updated by: Topcon Medical Systems, Inc.
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.

Study Type

Interventional

Phase

  • Not Applicable

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

Description

Inclusion Criteria

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

Exclusion Criteria

  1. Subject with history of ocular disease or ocular pathology
  2. Subjects unable to complete all OCT imaging modes

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects Presenting With Normal Eyes
Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton
Device: DRI OCT Triton
DRI OCT Triton using micro-electro-mechanical short cavity tunable laser
Device: DRI OCT Triton
DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OCT image quality
Time Frame: 5 minutes
5 minutes
OCT angiography image quality
Time Frame: 5 minutes
5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Full Retinal Thickness
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

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

Sponsor

Topcon Medical Systems, Inc.

Investigators

  • Principal Investigator: Zhenguo Wang, PhD, 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)

December 14, 2016

Primary Completion (Actual)

June 12, 2017

Study Completion (Actual)

July 2, 2017

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 9, 2016

First Posted (Estimate)

December 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Topcon Tabil-801-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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