OCT Image Quality Performance Evaluation

Sponsor

Topcon Medical Systems, Inc. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02991027

Collaborator

(none)

Enrollment

Location

Arm

6.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Device: DRI OCT Triton	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

OCT Image Quality Performance Evaluation

Actual Study Start Date :

Dec 14, 2016

Actual Primary Completion Date :

Jun 12, 2017

Actual Study Completion Date :

Jul 2, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

OCT image quality [5 minutes]
OCT angiography image quality [5 minutes]

Secondary Outcome Measures

Full Retinal Thickness [5 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria

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

Exclusion Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Topcon Medical Systems Inc.	Oakland	New Jersey	United States	07436

Sponsors and Collaborators

Topcon Medical Systems, Inc.

Investigators

Principal Investigator: Zhenguo Wang, PhD, Topcon Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Topcon Medical Systems, Inc.

ClinicalTrials.gov Identifier:

NCT02991027

Other Study ID Numbers:

Topcon Tabil-801-2016

First Posted:

Dec 13, 2016

Last Update Posted:

Dec 16, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Topcon Medical Systems, Inc.

no known ocular pathology

Study Results

No Results Posted as of Dec 16, 2021