Evaluation of the Repeatability and Reproducibility of An... | NCT02911883

Studies
Evaluation of the Repeatability and Reproducibility of AngioVue

NCT02911883

Sponsor

Optovue

Status

Completed

Last Update Posted

Jun 20, 2017Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Normal, Glaucoma & Retinal Pathology

Interventions

Optical Coherence Tomography Angiography

Countries

Not provided

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 2017

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

Aug 29, 2016Actual

Primary Completion Date

Feb 1, 2017Actual

Completion Date

Feb 2, 2017Actual

First Submitted Date

Sep 20, 2016

First Submission Date that Met QC Criteria

Sep 21, 2016

First Posted Date

Sep 22, 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 16, 2017

Last Update Posted Date

Jun 20, 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

Description Module

Brief Summary

The purpose of this study is to assess the repeatability and reproducibility of measurements of the vascular structures and the anatomical structures of the posterior pole of the eye based on AngioVue volume scans in normal subjects, glaucoma patients, and retina patients.

Detailed Description

Not provided

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Normal	Not having glaucoma or retinal pathology	Device: Optical Coherence Tomography Angiography
Glaucoma	Having glaucoma.	Device: Optical Coherence Tomography Angiography
Retina	Having retinal pathology	Device: Optical Coherence Tomography Angiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography Angiography	Device		Glaucoma Normal Retina

Measure	Description	Time Frame
Retina vasculature		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal
- Age > 18.
- No retinal pathology or glaucoma.
Glaucoma patient
- Age > 18.
- Have glaucoma.
Retina patient
- Age > 18.
- Have retina pathology.

Exclusion Criteria:

Normal
- Unable to complete required exams.
- Poor quality image data.
Glaucoma patient
- Unable to complete required exams.
- Poor quality image data.
- Retinal pathology.
Retina patient
- Unable to complete required exams.
- Poor quality image data.
- Glaucoma.

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

Seeing eye doctor for routine or follow-up care

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided