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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date March 15, 2017
First Posted Date April 12, 2017
Last Update Posted Date March 21, 2019
Actual Study Start Date March 2, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 5, 2017)
  • Prevalence of Glaucoma in Northern Ireland [ Time Frame: 1 day [2 hours] ]
    Prevalence of Glaucoma in Northern Ireland
  • Diagnostic Accuracy of Spectral Domain OCT [ Time Frame: 1 day [2 hours] ]
    Diagnostic Accuracy of Spectral Domain OCT
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03109665 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing
Official Title Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing
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.

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?
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Glaucoma
Intervention
  • Diagnostic Test: SD-OCT Angiography
    SD-OCT Angiography
  • Diagnostic Test: SD-OCT
    SD-OCT
Study Groups/Cohorts Glaucoma within NICOLA
NICOLA study Participants Eligible for GwNICOLA by meeting inclusion criteria
Interventions:
  • Diagnostic Test: SD-OCT Angiography
  • Diagnostic Test: SD-OCT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 20, 2019)
129
Original Estimated Enrollment
 (submitted: April 5, 2017)
200
Actual Study Completion Date November 30, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03109665
Other Study ID Numbers B16/66
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Professor Augusto Azuara-Blanco, Queen's University, Belfast
Study Sponsor Queen's University, Belfast
Collaborators Not Provided
Investigators
Principal Investigator: Augusto Azuara-Blanco, PhD, MD Queens University Belfast
PRS Account Queen's University, Belfast
Verification Date March 2019