Clinical Validation Study for iVue | NCT01242553

Studies
Clinical Validation Study for iVue

NCT01242553

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 28, 2017Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Normal and Ocular Pathology

Interventions

Not provided

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

Nov 2010

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

Oct 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 16, 2010

First Posted Date

Nov 17, 2010Estimated

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

Sep 26, 2017

Last Update Posted Date

Sep 28, 2017Actual

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

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		Normal results from clinical exam and free of ocular pathology.
Retina		Clinical exam results consistent with retina pathology
Glaucoma		Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Cornea		Clinical exam results consistent with cornea pathology.

Interventions

Not provided

Measure	Description	Time Frame
thickness of ocular structures

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal: Normal results from clinical exam and free of ocular pathology.
Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Cornea: Clinical exam results consistent with cornea pathology.
Retina: Clinical exam results consistent with retina pathology

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

Volunteers with various ocular pathology or no ocular pathology.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Hee, MD	Pacific Eye Specialists	Principal Investigator
Nalin Mehta, MD	Colorado Retina Center	Principal Investigator
Michael Sinai, PhD	Optovue	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pacific Eye Specialists		Daly City	California	94015	United States
Colorado Retina Center