NCT03631069

Brief Summary

This retrospective case control explores the retinal features of dementia associated with neurodegenerative diseases, particularly Alzheimer's disease. By linking a pseudonymised dataset of three-dimensional retinal scans, called optical coherence tomography, with nationally held data on dementia, corresponding characteristics will be evaluated through descriptive statistics and machine learning techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

2.9 years

First QC Date

August 10, 2018

Last Update Submit

September 16, 2021

Conditions

Dementia AlzheimersDementiaDementia, VascularDementia Senile

Outcome Measures

Primary Outcomes (3)

  • Retinal nerve fiber layer thickness

    1 year

  • Ganglion cell layer thickness

    1 year

  • Macular volume

    1 year

Study Arms (2)

Dementia

People with hospital episode statistics labels of dementia

Normal

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients over the age of 40 who have undergone an optical coherence tomography scan at Moorfields Eye Hospital NHS Foundation Trust.

You may qualify if:

  • All patients over the age of 40 who have undergone an optical coherence tomography scan at Moorfields Eye Hospital NHS Foundation Trust

You may not qualify if:

  • Poor quality image

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaDementia, Vascular

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pearse Keane, MD FRCOphth

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

August 15, 2018

Study Start

September 1, 2019

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations

GB(1)