NCT02788695

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. 1.Quantify age-related decline in a variety of visual functions within a populations based cohort.
  2. 2.Explore the mechanisms underlying age-related visual impairments.
  3. 3.Investigate how visual function impacts vision related quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
842

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

3.5 years

First QC Date

April 28, 2016

Last Update Submit

August 12, 2019

Conditions

Aging

Keywords

Visual Nonspecific

Outcome Measures

Primary Outcomes (1)

  • Rate of decline of visual function with age

    24 months

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • No diagnosed ocular disease.
  • Non-diabetic.

You may not qualify if:

  • Any diagnosed ocular disease.
  • Diabetic.
  • Cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NI Clinical Research Facility

Belfast, Northern Ireland, BT9 7AB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample.

Study Officials

  • Ruth Hogg

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 28, 2016

First Posted

June 2, 2016

Study Start

November 1, 2014

Primary Completion

April 30, 2018

Study Completion

December 31, 2018

Last Updated

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)