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Novel Markers for Detecting Early Progression of Glaucoma

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ClinicalTrials.gov Identifier: NCT03108443
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Balwantray Chauhan, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment
Glaucoma 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.


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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Markers for Detecting Early Progression of Glaucoma
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Optic nerve head (ONH) anatomy [ Time Frame: Changes over the 5 year course of the study ]
    Measure changes in the structure of the ONH



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108443


Contacts
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Contact: Balwantray Chauhan, PHD 902-473-3202 bal@dal.ca
Contact: Glen Sharpe, MSC 902-473-3981 glensharpe@dal.ca

Locations
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Canada, Nova Scotia
Eye Care Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Glen Sharpe, MSc    902-473-3981    glensharpe@dal.ca   
Sponsors and Collaborators
Balwantray Chauhan
Investigators
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Principal Investigator: Balwantray Chauhan, PHD Nova Scotia Health Authority

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Responsible Party: Balwantray Chauhan, Mathers Professor and Research Director, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03108443     History of Changes
Other Study ID Numbers: 1022071
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases