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Completed

NCT Number: NCT03109665

Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Ireland Clinical Research Facility

Belfast, Northern Ireland, BT12 6BA, United Kingdom

About this study

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

  • What is the prevalence of glaucoma within the NICOLA cohort and which systemic and socioeconomic factors influence its prevalence?
  • What is the diagnostic accuracy (sensitivity and specificity) of Retinal Nerve Fibre Layer (RNFL) thickness measurements in the diagnosis of glaucoma?
  • What is the diagnostic accuracy (sensitivity and specificity) of macular thickness analysis in the diagnosis of glaucoma?
  • What is the agreement between intraocular pressure measurement by Ocular Response Analyser (ORA) and Goldmann tonometry?
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of the NICOLA study who gave permission to be contacted by the NICOLA study team in future and
  • 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

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

Treatment and study plan

SD-OCT Angiography

Diagnostic Test

SD-OCT Angiography

SD-OCT

Diagnostic Test

SD-OCT

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Acronym: GwNICOLA

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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