Evaluation of the Signal to Noise Ratio at Various Retina... | NCT02982174

Studies
Evaluation of the Signal to Noise Ratio at Various Retinal Layers

NCT02982174

Sponsor

Topcon Medical Systems, Inc.

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Healthy Eyes

Interventions

3D OCT-1 Maestro
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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Jan 2017Actual

First Submitted Date

Nov 29, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 5, 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

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

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

Compare the signal to noise ratio of each device at various retinal layers.

Detailed Description

Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal Eyes		Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton	Device: 3D OCT-1 Maestro Device: DRI OCT Triton

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3D OCT-1 Maestro	Device	Image acquisition of the posterior surface of the eye	Normal Eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Signal to noise ratio between SD OCT and SS OCT		5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients > 18 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.
Subjects who agree to participate in the study.

Exclusion Criteria:

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

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

30 subjects willing to participate in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei-Chieh Huang, PhD	Topcon Medical Systems, Inc.	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