Data Collection of OCT and OCTA-based Ocular Measurements | NCT03887104

Studies
Data Collection of OCT and OCTA-based Ocular Measurements

NCT03887104

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 3, 2019Actual

Enrollment

482Actual

Phase

Not provided

Conditions

Eyes Without Ocular Pathology

Interventions

SD-OCT

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

Aug 2019

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

Feb 8, 2019Actual

Primary Completion Date

Jul 11, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 20, 2019

First Posted Date

Mar 22, 2019Actual

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

Aug 30, 2019

Last Update Posted Date

Sep 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Data Collection of OCT and OCTA-based Ocular Measurements

Detailed Description

The purpose of this study is to collect measurements of anatomical structures of the posterior pole of the eye based on OCT scans in subjects without clinical signs of pathology.

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

482Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SD-OCT	Device	Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal thickness	micrometers	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No glaucoma
No retinal pathology
No systemic disorders impacting the eye
No ocular surgery or medical treatment of ocular condition

Exclusion Criteria:

High IOP
Poor vision
Clinical findings consistent with pathology
Unable to complete the study

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Persons having eyes without ocular pathology

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Care Center		Pomona	California	91766	United States
Eye Care Institute