NCT03108443

Brief Summary

Current methods of detecting glaucoma and monitoring its progression over time involve visual assessment of the optic nerve, thickness measurements of nerve tissue in the eye (using optical coherence tomography, OCT) as well as functional tests which measure peripheral, or side, vision. The objective of this study is to determine if a new technique of measuring blood flow in the eye, using OCT, can be used to better detect and/or monitor changes in glaucoma patients and suspects than these methods.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

8.1 years

First QC Date

April 5, 2017

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood flow

    Establish whether blood flow changes occur and if there are differences in the groups.

    Changes over the 5 year course of the study

Secondary Outcomes (1)

  • Optic nerve head (ONH) anatomy

    Changes over the 5 year course of the study

Study Arms (2)

Glaucoma

Subjects identified as having glaucoma. No interventions will be performed.

Diagnostic Test: Optical Coherence tomography angiography

Healthy controls

Subjects identified as having healthy eyes with no disease.

Diagnostic Test: Optical Coherence tomography angiography

Interventions

All subjects will have OCT angiography imaging performed

GlaucomaHealthy controls

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients recruited from a Primary Care Clinic Healthy control subjects recruited from the general population

You may qualify if:

  • visual acuity ≥ 6/12
  • glaucomatous ONH change
  • glaucomatous visual field loss with a positive Glaucoma Hemifield Test

You may not qualify if:

  • non-glaucomatous ocular disease
  • chronic systemic disease or treatment affecting the visual field
  • refraction exceeding 6 D equivalent sphere or 3 D astigmatism
  • inability to provide informed consent
  • Control Group
  • visual acuity ≥ 6/12
  • normal eye examination with intraocular pressure ≤ 21 mm Hg
  • normal visual field and negative Glaucoma Hemifield Test
  • chronic ocular disease
  • chronic systemic disease or treatment affecting the visual field
  • refraction exceeding 6 D equivalent sphere or 3 D astigmatism
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Care Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Balwantray Chauhan, PHD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mathers Professor and Research Director

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

April 1, 2018

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations