Ocular Imaging Study Using Advanced OCT

July 7, 2016 updated by: Steven Schwartz, University of California, Los Angeles
The purpose of this study is to evaluate this AngioScan angiography software on patients with various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically used camera, but the AngioScan angiography software is not FDA approved. Investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. Images collected in this study may be compared to other images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Stein Eye Institute/Geffen School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 115 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with retinal vascular abnormalities

Description

Inclusion Criteria:

• Any patient with abnormal retinal findings as determined by investigators.

Exclusion Criteria:

  • Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging.
  • Participants who are unable to maintain retinal fixation on a specified target.
  • Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place.
  • Patients with media opacity which preclude high quality imaging.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Retina abnormalities
Subjects with various retina vascular disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal vascular abnormalities imaged by OCT Angiography and en face analysis of macular disorders
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSEI Nidek Advanced OCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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