Evaluation of the Repeatability and Reproducibility of AngioVue

June 16, 2017 updated by: Optovue
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Seeing eye doctor for routine or follow-up care

Description

Inclusion Criteria:

  1. Normal

    • Age > 18.
    • No retinal pathology or glaucoma.

  2. Glaucoma patient

    • Age > 18.
    • Have glaucoma.

  3. Retina patient

    • Age > 18.
    • Have retina pathology.

Exclusion Criteria:

  1. Normal

    • Unable to complete required exams.
    • Poor quality image data.

  2. Glaucoma patient

    • Unable to complete required exams.
    • Poor quality image data.
    • Retinal pathology.

  3. Retina patient

    • Unable to complete required exams.
    • Poor quality image data.
    • Glaucoma.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retina vasculature
Time Frame: Day 1
Day 1

Collaborators and Investigators

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

Sponsor

Optovue

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 (Actual)

August 29, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 16, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200-51133

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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