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Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing (GwNICOLA)

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ClinicalTrials.gov Identifier: NCT03109665
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Augusto Azuara-Blanco, Queen's University, Belfast

Brief Summary:

Glaucoma is the leading cause of irreversible blindness worldwide. It is caused by damage to the optic nerve between the back of the eye and the brain leading to progressive blindness. The cause is poorly understood but ageing, increased intraocular pressure (IOP) and genetics are all likely to play a role. There is no cure for glaucoma but treatments are available which slow progression. Because vision cannot be restored once lost, early detection, monitoring and early treatment are all essential to preserve visual function.

The condition is diagnosed using a combination of the appearance of the optic nerve on clinical examination or photograph and visual field testing (perimetry). Measurement of IOP and measurement of the thickness of the retinal layers at the back of the eye complement diagnostic decisions.

The Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA) study does not include perimetry in the series of tests carried out on all participants but does include photography of the optic nerve, measurement of IOP and measurement of retinal thickness. Therefore we propose to invite back participants of the NICOLA study who have abnormal optic discs and high eye pressure to return for perimetry to confirm a diagnosis of glaucoma. Calling back participants for perimetry is essential to make the diagnosis not only for estimating prevalence but also for identifying participant's ill-health.

The primary aim of this study is to quantify the number of participants in the NICOLA study who have glaucoma and report its risk factors. This will allow an estimate of the number of people in the whole of NI with glaucoma. We will also perform a series of novel tests using state-of-the-art technologies to assess if they are better than current tests at diagnosing glaucoma. This may enable better informed decisions about policy decisions in eyecare.


Condition or disease Intervention/treatment
Glaucoma Diagnostic Test: SD-OCT Angiography Diagnostic Test: SD-OCT

Detailed Description:

Purpose and design: This study will answer the following research questions:

  1. What is the prevalence of glaucoma within the NICOLA cohort and which systemic and socioeconomic factors influence its prevalence?
  2. What is the diagnostic accuracy (sensitivity and specificity) of Retinal Nerve Fibre Layer (RNFL) thickness measurements in the diagnosis of glaucoma?
  3. What is the diagnostic accuracy (sensitivity and specificity) of macular thickness analysis in the diagnosis of glaucoma?
  4. What is the agreement between intraocular pressure measurement by Ocular Response Analyser (ORA) and Goldmann tonometry?
  5. What is the correlation between structural (circumpapillary RNFL or macular Ganglion Cell Complex thickness) or functional measurements (retinal oximetry or perimetry) and Optical Coherence Tomography angiography parameters (% vessel density and vessel calibre) in the assessment of glaucoma?

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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Glaucoma within NICOLA
NICOLA study Participants Eligible for GwNICOLA by meeting inclusion criteria
Diagnostic Test: SD-OCT Angiography
SD-OCT Angiography

Diagnostic Test: SD-OCT
SD-OCT




Primary Outcome Measures :
  1. Prevalence of Glaucoma in Northern Ireland [ Time Frame: 1 day [2 hours] ]
    Prevalence of Glaucoma in Northern Ireland

  2. Diagnostic Accuracy of Spectral Domain OCT [ Time Frame: 1 day [2 hours] ]
    Diagnostic Accuracy of Spectral Domain OCT



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:   No
Sampling Method:   Probability Sample
Study Population
NICOLA Study - Random sample of 8500 non-institutionalised adults >50 years from Northern Ireland GwNICOLA participants derived from NICOLA Study
Criteria

Inclusion Criteria:

  1. Participants of the NICOLA study who gave permission to be contacted by the NICOLA study team in future and
  2. Vertical cup to disc ratio ≥0.7 and/or inter-eye asymmetry ≥0.2 or neuroretinal rim ≤0.1 or intraocular pressure ≥25 mmHg.

Exclusion Criteria:

  1. Non English speakers or
  2. Participants of the NICOLA study who did not give permission to be contacted by the NICOLA study team in future

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): NCT03109665


Locations
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United Kingdom
Northern Ireland Clinical Research Facility
Belfast, Northern Ireland, United Kingdom, BT12 6BA
Sponsors and Collaborators
Queen's University, Belfast
Investigators
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Principal Investigator: Augusto Azuara-Blanco, PhD, MD Queens University Belfast

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Responsible Party: Professor Augusto Azuara-Blanco, Professor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03109665     History of Changes
Other Study ID Numbers: B16/66
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases