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OCT Image Quality Performance Evaluation

NCT ID: NCT02991027

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-14

Study Completion Date

2017-07-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Eyes

Keywords

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no known ocular pathology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects Presenting With Normal Eyes

Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton

Group Type EXPERIMENTAL

DRI OCT Triton

Intervention Type DEVICE

DRI OCT Triton using micro-electro-mechanical short cavity tunable laser

DRI OCT Triton

Intervention Type DEVICE

DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser

Interventions

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DRI OCT Triton

DRI OCT Triton using micro-electro-mechanical short cavity tunable laser

Intervention Type DEVICE

DRI OCT Triton

DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Topcon Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenguo Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Topcon Corporation

Locations

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Topcon Medical Systems Inc.

Oakland, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Topcon Tabil-801-2016

Identifier Type: -

Identifier Source: org_study_id