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The Northern Ireland Sensory Ageing Study (NISA)

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: NCT02788695
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
College of Optometrists
Information provided by (Responsible Party):
Ruth Hogg, Queen's University, Belfast

Study Description
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Brief 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. Investigate how visual function impacts vision related quality of life.

Condition or disease
Aging

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
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Study Type : Observational
Actual Enrollment : 842 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Northern Ireland Sensory Ageing Study
Study Start Date : November 2014
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of decline of visual function with age [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Blood sample.

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • No diagnosed ocular disease.
  • Non-diabetic.

Exclusion Criteria:

  • Any diagnosed ocular disease.
  • Diabetic.
  • Cognitive impairment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788695


Locations
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United Kingdom
NI Clinical Research Facility
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Sponsors and Collaborators
Queen's University, Belfast
College of Optometrists
Investigators
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Principal Investigator: Ruth Hogg Queen's University, Belfast
More Information
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Responsible Party: Ruth Hogg, Doctor, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02788695    
Other Study ID Numbers: 14.25
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ruth Hogg, Queen's University, Belfast:
Visual Nonspecific