GlaucomaGwNICOLANCT03109665
Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing
An observational study of Glaucoma, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- SD-OCT Angiography and SD-OCT
- How many people
- 129 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2017to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NICOLA Study - Random sample of 8500 non-institutionalised adults >50 years from Northern Ireland GwNICOLA participants derived from NICOLA Study
Who may be able to join
- 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.
Who cannot join
- Non English speakers or
- Participants of the NICOLA study who did not give permission to be contacted by the NICOLA study team in future
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern Ireland Clinical Research Facility
Belfast, Northern Ireland, BT12 6BA
About this study
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.
Read more
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.
Read the detailed description
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?
- Conditions
- Glaucoma
- Being tested
- SD-OCT Angiography, SD-OCT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-OCT AngiographyDiagnostic test
SD-OCT Angiography
SD-OCTDiagnostic test
SD-OCT
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma within NICOLA | NICOLA study Participants Eligible for GwNICOLA by meeting inclusion criteria Receives: Diagnostic Test: SD-OCT Angiography; Diagnostic Test: SD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Glaucoma in Northern Ireland
Prevalence of Glaucoma in Northern Ireland
Measured: 1 day [2 hours]
Diagnostic Accuracy of Spectral Domain OCT
Diagnostic Accuracy of Spectral Domain OCT
Measured: 1 day [2 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start2 Mar 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Augusto Azuara-Blanco, Queen's University, Belfast
- Investigators
- Augusto Azuara-Blanco, PhD, MD, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109665
- Sponsor's protocol ID
- B16/66
- Acronym
- GwNICOLA
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Within Northern Ireland Cohort for the Longitudinal Study of Ageing
- ClinicalTrials.gov ID
- NCT03109665
- Acronym / sponsor ID
- GwNICOLA / B16/66
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma within NICOLA | – | Diagnostic Test: SD-OCT Angiography, Diagnostic Test: SD-OCTNICOLA study Participants Eligible for GwNICOLA by meeting inclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NICOLA Study - Random sample of 8500 non-institutionalised adults >50 years from Northern Ireland GwNICOLA participants derived from NICOLA Study
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Non English speakers or
- Participants of the NICOLA study who did not give permission to be contacted by the NICOLA study team in future
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SD-OCT AngiographySD-OCT Angiography | Diagnostic test | Glaucoma within NICOLA |
| SD-OCTSD-OCT | Diagnostic test | Glaucoma within NICOLA |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augusto Azuara-Blanco, PhD, MD principal investigator
Queens University Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Glaucoma in Northern Ireland (time frame: 1 day [2 hours]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.