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Detecting Dementia in the Retina Using Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT03631069
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

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.

Condition or disease
Dementia Alzheimers Dementia Dementia, Vascular Dementia Senile

Detailed Description:

By 2025, it is estimated that approximately 1 million people in the United Kingdom (UK) will suffer from dementia, a syndrome associated with progressive decline in brain function. While there is currently no cure for most types of dementia, early diagnosis can help patients receive the appropriate treatment and support to help maintain mental function.

The focus of this project is to identify changes in retinal structure associated with dementia. In collaboration with bioinformatics experts at University College London (UCL), the investigators propose to analyse our repository of >1 million retinal scans, termed optical coherence tomography (OCT), performed regularly on patients since 2008. OCT scans will be linked at a patient level to data from the Hospital Episode Statistics (HES) database to identify those who have been diagnosed with dementia or went on the develop dementia. Thus, a pseudonymised classified dataset of retinal scans will be generated for qualitative and quantitative analysis. The primary objective is to characterise changes in the layers of the retina associated with dementia. Machine learning techniques may also be employed to identify novel patterns of retinal change associated with dementia.


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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Detecting Dementia in the Retina: a Big Data Machine Learning Approach
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Group/Cohort
Dementia
People with hospital episode statistics labels of dementia
Normal



Primary Outcome Measures :
  1. Retinal nerve fiber layer thickness [ Time Frame: 1 year ]
  2. Ganglion cell layer thickness [ Time Frame: 1 year ]
  3. Macular volume [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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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): NCT03631069


Contacts
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Contact: Pearse Keane, MD FRCOphth 02072533411 moorfields.nhs@gmail.com

Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation Trust Not yet recruiting
London, United Kingdom, EC1V 2PD
Contact: Pearse Keane, MD FRCOphth    02072533411    moorfields.nhs@gmail.com   
Principal Investigator: Pearse Keane, MD FRCOphth         
Sub-Investigator: Siegfried K Wagner, MA FRCOphth         
Sub-Investigator: Christos Bergeles, PhD         
Sub-Investigator: Hugh Montgomery, MD MRCP         
Sub-Investigator: Nikolas Pontikos, PhD         
Sub-Investigator: Axel Petzold, MD PhD         
Sub-Investigator: Fintan Hughes, MBBS         
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Pearse Keane, MD FRCOphth University College, London

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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03631069     History of Changes
Other Study ID Numbers: KEAP1004
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases