Non-Invasive Imaging of the Human Eye | NCT02432898

Studies
Non-Invasive Imaging of the Human Eye

NCT02432898

Sponsor

Topcon Medical Systems, Inc.

Status

Withdrawn

Last Update Posted

Jun 8, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Willing and Able Subjects for Ocular Imaging

Interventions

3D OCT-1
3D OCT-2000
DRI OCT-1
NW-300
CT-1P
TRK-2P
SP-1P
SL-D701
MC-4S

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No subjects were enrolled in this protocol

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Nov 20, 2014

First Submission Date that Met QC Criteria

Apr 28, 2015

First Posted Date

May 4, 2015Estimated

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

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluate the clinical information obtained from the use of the machines.

Detailed Description

Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Healthy Eyes		Normal healthy eyes with no known ocular diseases	Device: 3D OCT-1 Device: 3D OCT-2000 Device: DRI OCT-1 Device: NW-300 Device: CT-1P Device: TRK-2P Device: SP-1P Device: SL-D701 Device: MC-4S

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D OCT-1	Device	Spectral Domain OCT Device	Normal Healthy Eyes
3D OCT-2000

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Device Evaluation	Determine Clinical Utility, Efficacy, and Safety	1 Hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.

Exclusion Criteria:

History of ocular pathology.
History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
History of systemic disease
fixation problems which may prevent obtaining good quality images in the eye.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Normal subjects will be recruited from Topcon Medical Systems.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Danny Leung	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

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided