Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing

NCT03109665 | Completed

• 1 other identifier: B16/66
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Prevalence of Glaucoma in Northern Ireland

  Prevalence of Glaucoma in Northern Ireland

  1 day [2 hours]

• Diagnostic Accuracy of Spectral Domain OCT

  Diagnostic Accuracy of Spectral Domain OCT

  1 day [2 hours]

Study Arms (1)

Glaucoma within NICOLA

NICOLA study Participants Eligible for GwNICOLA by meeting inclusion criteria

Diagnostic Test: SD-OCT Angiography; Diagnostic Test: SD-OCT

Interventions

SD-OCT Angiography DIAGNOSTIC_TEST

SD-OCT Angiography

Glaucoma within NICOLA

SD-OCT DIAGNOSTIC_TEST

SD-OCT

Glaucoma within NICOLA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Northern Ireland Clinical Research Facility

Belfast, Northern Ireland, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Augusto Azuara-Blanco, PhD, MD

  Queens University Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 12, 2017
• Study Start: March 2, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)