Novel Markers for Detecting Early Progression of Glaucoma

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Diagnostic test: Optical Coherence tomography angiography

Detailed Description

Changes in the superficial optic nerve head (ONH) surface and loss of retinal nerve fibre layer (RNFL) thickness detected with clinical imaging are predictive of future visual field loss. Imaging of the deep ONH, the likely origin of glaucomatous damage, represents the next logical next step, but has eluded clinicians because of the lack of capable technology.

New advances in optical coherence tomography (OCT) imaging now offer an exciting opportunity to close the gap between the histomorphometric knowledge on deep ONH changes gained with research in experimental monkey glaucoma and imaging in clinical glaucoma.

There is compelling evidence that gross ONH and retinal hemodynamic changes are functional indicators of glaucoma progression. Accurate tracking of blood flow in the ONH is a logical step, but has evaded researchers for several reasons including the highly reflective ONH tissue which variably inhibits signal penetration making the complex nature of retinal and posterior ciliary contributions to ONH flow difficult to segregate. Even though glaucoma damage originates in the ONH, retinal ganglion cell (RGC) axons may show the earliest functional alterations as they have high metabolic demand and vulnerability to damage. Therefore, tracking blood flow in the RNFL, which is highly segmental and resolvable, could be a better and more sensitive approach compared to that in the ONH. The macula contains almost 50% of the entire RGC population; likewise, monitoring blood flow in the macular inner vascular plexus corresponding to the ganglion cell layer (GCL) is likely to be highly informative for glaucoma progression. OCT based angiography (OCTA), which maps vessel density in different retinal vascular beds with unparalleled axial resolution, will finally allow us to quantify highly localized parameters related to blood flow and identify patients with higher progression risk. Current data analysis of progression detection based on inter-subject or population-based variability models are inefficient, leading to false-positive and false-negative results. Innovative data analysis techniques that build accurate models of intra-subject variability will add cumulative value to the novel imaging markers for progression.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Eye Care Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Glaucoma Group

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Inclusion Criteria:

• visual acuity ≥ 6/12
• normal eye examination with intraocular pressure ≤ 21 mm Hg
• normal visual field and negative Glaucoma Hemifield Test

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Glaucoma; Subjects identified as having glaucoma. No interventions will be performed.	Diagnostic test: Optical Coherence tomography angiography; All subjects will have OCT angiography imaging performed
Healthy controls; Subjects identified as having healthy eyes with no disease.	Diagnostic test: Optical Coherence tomography angiography; All subjects will have OCT angiography imaging performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic nerve head (ONH) anatomy	Measure changes in the structure of the ONH	Changes over the 5 year course of the study

Collaborators and Investigators

• Sponsor: Balwantray Chauhan
• Investigators: Principal Investigator: Balwantray Chauhan, PHD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 1022071

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