Retinal Imaging in Neurodegenerative Disease

NCT03233646 | Recruiting FDA Device

• 1 other identifier: Pro00111831
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment; Parkinson's Disease; Multiple Sclerosis; Huntington Disease; Lewy Body Dementia; Frontotemporal Dementia; Amyotrophic Lateral Sclerosis (ALS); APOE-4 Positive; Traumatic Brain Injury; Concussion; Post-Traumatic Stress Disorder; Down Syndrome; Neuro-Degenerative Disease; Normal Cognition

Keywords

OCT angiography (OCTA); Optical Coherence Tomography (OCT); Vessel Density; Superficial Capillary Plexus; Retinal microvasculature; Scanning Laser Ophthalmoscopy; Ultra-widefield (UWF) Imaging; Perfusion Density; Retinal Nerve Fiber Layer; Ganglion Cell Inner Plexiform Layer; Choroidal Vascularity Index

Outcome Measures

Primary Outcomes (9)

• Change in ganglion cell-inner plexiform layer (GCIPL) thickness

  Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula

  Baseline, 1 year

• Change in retinal nerve fiber layer (RNFL) thickness

  Retinal nerve fiber layer thickness as measured on optical coherence tomography scan of macula

  Baseline, 1 year

• Change in central subfield thickness (CST)

  Central subfield thickness as measured on optical coherence tomography scan of macula

  Baseline, 1 year

• Change in choroidal vascularity index (CVI)

  Choroidal vascularity index as measured using the COIN software in 1500 um area centered on the fovea

  Baseline, 1 year

• Change in foveal avascular zone (FAZ) area

  Foveal avascular zone area as measured in the superficial capillary plexus on 3mm optical coherence tomography angiography scan of the macula

  Baseline, 1 year

• Change in average perfusion density (PD)

  Average perfusion density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula

  Baseline, 1 year

• Change in average vessel density (VD)

  Average vessel density as measured in the ETDRS 3mm and 6mm circle and rings on optical coherence tomography angiography scan of the macula

  Baseline, 1 year

• Change in average capillary perfusion density (CPD)

  Capillary perfusion density as measured on peripapillary 4.5mm optical coherence tomography angiography scan

  Baseline, 1 year

• Change in average capillary flux index (CFI)

  Capillary flux index as measured on peripapillary 4.5mm optical coherence tomography angiography scan

  Baseline, 1 year

Secondary Outcomes (3)

• Change in retinal vessel tortuosity

  Baseline, 1 year

• Change in retinal vessel width gradient

  Baseline, 1 year

• Change in retinal vessel fractal dimension

  Baseline, 1 year

Study Arms (2)

Case

Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

Device: Retinal and Choroidal Imaging

Controls

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Device: Retinal and Choroidal Imaging

Interventions

Retinal and Choroidal Imaging DEVICE

Non-invasive OCT, OCTA, and UWF fundus photography of retina

Case; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurology Clinics and the community.

You may qualify if:

• Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)
• Adults without neurodegenerative disease

You may not qualify if:

• Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.
• Eyes that have had intraocular surgery, other than cataract surgery.

Sponsors & Collaborators

• Duke University: lead
• University of Edinburgh in Scotland: collaborator
• Tan Tock Seng Hospital in Singapore: collaborator
• Queens University of Belfast United Kingdom: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

Related Publications (2)

• Zhao W, Robbins CB, Grewal DS, Patel H, Soundararajan S, Liu AJ, Johnson KG, Agrawal R, Petrella JR, Stinnett SS, Parker D, Fekrat S. Correlating retinal and choroidal vascular parameters with volumetric MRI in Alzheimer's disease and amnestic mild cognitive impairment. BMC Ophthalmol. 2025 Jul 1;25(1):365. doi: 10.1186/s12886-025-04157-x.

  PMID: 40598011 DERIVED

• Robbins CB, Akrobetu D, Ma JP, Stinnett SS, Soundararajan S, Liu AJ, Johnson KG, Grewal DS, Fekrat S. ASSESSMENT OF RETINAL MICROVASCULAR ALTERATIONS IN INDIVIDUALS WITH AMNESTIC AND NONAMNESTIC MILD COGNITIVE IMPAIRMENT USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2022 Jul 1;42(7):1338-1346. doi: 10.1097/IAE.0000000000003458.

  PMID: 35723922 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Parkinson Disease; Multiple Sclerosis; Huntington Disease; Lewy Body Disease; Frontotemporal Dementia; Amyotrophic Lateral Sclerosis; Brain Injuries, Traumatic; Brain Concussion; Stress Disorders, Post-Traumatic; Down Syndrome

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Cord Diseases; Motor Neuron Disease; Neuromuscular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders

Study Officials

• Sharon Fekrat, MD FACS FASRS

  Duke University

  PRINCIPAL INVESTIGATOR

• Dilraj Grewal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Fekrat, MD FACS FASRS

CONTACT

919-681-3937; imind@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: July 20, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)