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OCT Image Quality Performance Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991027
Recruitment Status : Unknown
Verified December 2016 by Topcon Medical Systems, Inc..
Recruitment status was:  Enrolling by invitation
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Brief Summary:
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.

Condition or disease Intervention/treatment Phase
Healthy Eyes Device: DRI OCT Triton Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: OCT Image Quality Performance Evaluation
Study Start Date : December 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

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




Primary Outcome Measures :
  1. OCT image quality [ Time Frame: 5 minutes ]
  2. OCT angiography image quality [ Time Frame: 5 minutes ]

Secondary Outcome Measures :
  1. Full Retinal Thickness [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991027


Locations
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United States, New Jersey
Topcon Medical Systems Inc.
Oakland, New Jersey, United States, 07436
Sponsors and Collaborators
Topcon Medical Systems, Inc.
Investigators
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Principal Investigator: Zhenguo Wang, PhD Topcon Corporation
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02991027    
Other Study ID Numbers: Topcon Tabil-801-2016
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Topcon Medical Systems, Inc.:
no known ocular pathology