NCT02911883

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

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 29, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

September 20, 2016

Last Update Submit

June 16, 2017

Conditions

Normal, Glaucoma & Retinal Pathology

Outcome Measures

Primary Outcomes (1)

  • Retina vasculature

    Day 1

Study Arms (3)

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

Optical Coherence Tomography AngiographyDEVICE
GlaucomaNormalRetina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

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

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 22, 2016

Study Start

August 29, 2016

Primary Completion

February 1, 2017

Study Completion

February 2, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06