OCT Image Quality Performance Evaluation | NCT02991027

Studies
OCT Image Quality Performance Evaluation

NCT02991027

Sponsor

Topcon Medical Systems, Inc.

Status

Withdrawn

Last Update Posted

Dec 16, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Healthy Eyes

Interventions

DRI OCT Triton
DRI OCT Triton

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No subjects needed for enrollment anymore

Expanded Access Info

Start Date

Dec 14, 2016Actual

Primary Completion Date

Jun 12, 2017Actual

Completion Date

Jul 2, 2017Actual

First Submitted Date

Dec 9, 2016

First Submission Date that Met QC Criteria

Dec 9, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2021

Last Update Posted Date

Dec 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects Presenting With Normal Eyes	Experimental	Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton	Device: DRI OCT Triton

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DRI OCT Triton	Device	DRI OCT Triton using micro-electro-mechanical short cavity tunable laser	Subjects Presenting With Normal Eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OCT image quality		5 minutes
OCT angiography image quality		5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Full Retinal Thickness		5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhenguo Wang, PhD	Topcon Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topcon Medical Systems Inc.		Oakland	New Jersey	07436	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided