Evaluation of RTVue XR With SSADA | NCT02535520

Studies
Evaluation of RTVue XR With SSADA

NCT02535520

Sponsor

Optovue

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

155Actual

Phase

Not provided

Conditions

Retina Vascular Pathology

Interventions

Not provided

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

Oct 2015

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 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 26, 2015

First Submission Date that Met QC Criteria

Aug 27, 2015

First Posted Date

Aug 28, 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

Mar 28, 2016

Last Update Posted Date

Mar 30, 2016Estimated

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

Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature. Consented subjects will undergo a series of images of the back of the eye using an Optical Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of clinical routine. SSADA images will be compared with conventional methods.

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

155Actual

Measure	Description	Time Frame
Agreement of SSADA to conventional angiography		Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18
Able and willing to complete exams
Patients in retina clinic that need angiography

Exclusion Criteria:

Unable to complete the required examinations and visits
Large amount of subretinal hemorrhage
Media opacity leading to poor quality images
Extreme refractive error leading to poor quality images
Pathologies in the anterior segment leading to poor quality images

Accepts Healthy Volunteers

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