GlaucomaNCT03108443
Novel Markers for Detecting Early Progression of Glaucoma
An observational study of Glaucoma, run by Balwantray Chauhan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Optical Coherence tomography angiography
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Glaucoma patients recruited from a Primary Care Clinic Healthy control subjects recruited from the general population
Who may be able to join
- visual acuity ≥ 6/12
- glaucomatous ONH change
- glaucomatous visual field loss with a positive Glaucoma Hemifield Test
- visual acuity ≥ 6/12
- normal eye examination with intraocular pressure ≤ 21 mm Hg
- normal visual field and negative Glaucoma Hemifield Test
Who cannot join
- 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
- chronic ocular disease
Show all 9Show fewer
- chronic systemic disease or treatment affecting the visual field
- refraction exceeding 6 D equivalent sphere or 3 D astigmatism
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Optical Coherence tomography angiography
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence tomography angiographyDiagnostic test
All subjects will have OCT angiography imaging performed
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Subjects identified as having glaucoma. No interventions will be performed. Receives: Diagnostic Test: Optical Coherence tomography angiography | |
| Healthy controls | Subjects identified as having healthy eyes with no disease. Receives: Diagnostic Test: Optical Coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
Establish whether blood flow changes occur and if there are differences in the groups.
Measured: Changes over the 5 year course of the study
Secondary outcomes (1)
Optic nerve head (ONH) anatomy
Measure changes in the structure of the ONH
Measured: Changes over the 5 year course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Apr 2018
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balwantray Chauhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Balwantray Chauhan, Nova Scotia Health Authority
- Investigators
- Balwantray Chauhan, PHD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108443
- Sponsor's protocol ID
- 1022071
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2017
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Markers for Detecting Early Progression of Glaucoma
- ClinicalTrials.gov ID
- NCT03108443
- Acronym / sponsor ID
- 1022071
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Balwantray ChauhanUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Diagnostic Test: Optical Coherence tomography angiographySubjects identified as having glaucoma. No interventions will be performed. |
| Healthy controls | – | Diagnostic Test: Optical Coherence tomography angiographySubjects identified as having healthy eyes with no disease. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Glaucoma patients recruited from a Primary Care Clinic Healthy control subjects recruited from the general population
Key inclusion criteria (6 listed)
- visual acuity ≥ 6/12
- glaucomatous ONH change
- glaucomatous visual field loss with a positive Glaucoma Hemifield Test
- visual acuity ≥ 6/12
- normal eye examination with intraocular pressure ≤ 21 mm Hg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence tomography angiographyAll subjects will have OCT angiography imaging performed | Diagnostic test | Glaucoma, Healthy controls |
Primary outcome
Blood flow
Time frame: Changes over the 5 year course of the study
Establish whether blood flow changes occur and if there are differences in the groups.
1 secondary outcome
Optic nerve head (ONH) anatomy
Time frame: Changes over the 5 year course of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Balwantray Chauhan, PHD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Balwantray Chauhan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow (time frame: Changes over the 5 year course of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.