AgingNISANCT02788695
The Northern Ireland Sensory Ageing Study
An observational study of Aging, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA). There are three key aims: 1. Quantify age-related decline in a variety of visual functions within a populations based cohort. 2. Explore the mechanisms underlying age-related visual impairments. 3. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 842 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to 31 Dec 2018
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study. 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included.
Who may be able to join
- No diagnosed ocular disease.
- Non-diabetic.
Who cannot join
- Any diagnosed ocular disease.
- Diabetic.
- Cognitive impairment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NI Clinical Research Facility
Belfast, Northern Ireland, BT9 7AB
About this study
A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA). There are three key aims:
- Quantify age-related decline in a variety of visual functions within a populations based cohort.
- Explore the mechanisms underlying age-related visual impairments.
- Investigate how visual function impacts vision related quality of life.
Read the detailed description
The investigators propose to put together a battery of test to assess different aspects of visual function and apply them to two groups of participants in order to explore differences in chronological and physiological aging.
Group 1: 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study and retinal/lens images assessed to confirm normality (drusen <63µm or clear retina, LOCS III <1). Those younger will be recruited via advertisements in the University and targeting friends and relatives or NICOLA participants. This will enable the rate of decline with age to be calculated. Linear, bilinear, and simple nonlinear candidate functions of parameter vs. age will be applied to determine which best characterises the change.
Group 2: 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included. This will enable mechanisms underlying individual differences in aging to be investigated. Normal aging will be determined from group 1 analysis and participants will be able to be categorised as aging well or aging poorly. Multivariate regression analysis will be used to investigate the relationship between visual function and lifestyle and environmental factors. Principal components analysis will be used to look at the relationships between visual parameters. These participants will also be asked to complete the NEIVFQ-25, to characterise visual function related quality of life and this will be compared with their measured visual function.
Visual function parameters measured after protocol refraction will include: Photopic and mesopic visual acuity and contrast sensitivity using City Occupational acuity-plus software17, near visual acuity, reading speed and SKILL card18, MAIA microperimetry and cone dark adaptation.19 Intra-ocular scatter will be assessed using the Oculus C-quant to assess the extent to which ocular factors are degrading vision.20 Three-point vernier acuity will also be measured as this is thought to stay stable throughout life.15 Time will be taken to ensure participants receive sufficient training to produce reliable thresholds.
All study visits will occur at the Welcome-Wolfson Clinic Research Facility.
- Conditions
- Aging
- Keywords
- Visual Nonspecific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - aged 20-90 years | 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study and retinal/lens images assessed to confirm normality. | |
| Group 2: aged 60 years | Group 2: 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline of visual function with age
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startNov 2014
- Primary completion30 Apr 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prospective
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- College of Optometrists
- Responsible party
- Principal investigator, Ruth Hogg, Queen's University, Belfast
- Investigators
- Ruth Hogg, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788695
- Sponsor's protocol ID
- 14.25
- Acronym
- NISA
- Status last verified
- Aug 2019
- First submitted
- 28 Apr 2016
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Northern Ireland Sensory Ageing Study
- ClinicalTrials.gov ID
- NCT02788695
- Acronym / sponsor ID
- NISA / 14.25
- Conditions
- Aging
- Keywords
- Visual Nonspecific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- College of Optometrists
- Study start
- Nov 2014
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
A visual function focused add-on study to the Northern Ireland Cohort for the Longitudinal Study of Ageing (NICOLA). There are three key aims:
- Quantify age-related decline in a variety of visual functions within a populations based cohort.
- Explore the mechanisms underlying age-related visual impairments.
- Investigate how visual function impacts vision related quality of life.
Detailed description
The investigators propose to put together a battery of test to assess different aspects of visual function and apply them to two groups of participants in order to explore differences in chronological and physiological aging.
Group 1: 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study and retinal/lens images assessed to confirm normality (drusen <63µm or clear retina, LOCS III <1). Those younger will be recruited via advertisements in the University and targeting friends and relatives or NICOLA participants. This will enable the rate of decline with age to be calculated. Linear, bilinear, and simple nonlinear candidate functions of parameter vs. age will be applied to determine which best characterises the change.
Group 2: 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included. This will enable mechanisms underlying individual differences in aging to be investigated. Normal aging will be determined from group 1 analysis and participants will be able to be categorised as aging well or aging poorly. Multivariate regression analysis will be used to investigate the relationship between visual function and lifestyle and environmental factors. Principal components analysis will be used to look at the relationships between visual parameters. These participants will also be asked to complete the NEIVFQ-25, to characterise visual function related quality of life and this will be compared with their measured visual function.
Visual function parameters measured after protocol refraction will include: Photopic and mesopic visual acuity and contrast sensitivity using City Occupational acuity-plus software17, near visual acuity, reading speed and SKILL card18, MAIA microperimetry and cone dark adaptation.19 Intra-ocular scatter will be assessed using the Oculus C-quant to assess the extent to which ocular factors are degrading vision.20 Three-point vernier acuity will also be measured as this is thought to stay stable throughout life.15 Time will be taken to ensure participants receive sufficient training to produce reliable thresholds.
All study visits will occur at the Welcome-Wolfson Clinic Research Facility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - aged 20-90 years | – | –25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study and retinal/lens images assessed to confirm normality. |
| Group 2: aged 60 years | – | –Group 2: 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 participants from each decade from 20-90. Those from 50+ will be recruited from the NICOLA study. 250 participants NICOLA participants aged 60 will be invited to participate; only those whose ocular images confirm normality will be included.
Key inclusion criteria (2 listed)
- No diagnosed ocular disease.
- Non-diabetic.
Key exclusion criteria (3 listed)
- Any diagnosed ocular disease.
- Diabetic.
- Cognitive impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of decline of visual function with age
Time frame: 24 months
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 13 Aug 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.
Ruth Hogg principal investigator
Queen's 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 Aging, 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 3 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 13 Aug 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?
Rate of decline of visual function with age (time frame: 24 months). 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 13 Aug 2019.