NCT02535520

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

August 26, 2015

Last Update Submit

March 28, 2016

Conditions

Retina Vascular Pathology

Outcome Measures

Primary Outcomes (1)

  • Agreement of SSADA to conventional angiography

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Seeing eye doctor for routine or follow-up care

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

August 28, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2016

Record last verified: 2015-10