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NCT Number: NCT03233646

Retinal Imaging in Neurodegenerative Disease

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.

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Key information

Conditions

Alzheimer's Disease APOE-4 Positive Abnormalities, Multiple Alzheimer Disease Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Chorea Chromosome Disorders Cognition Disorders Cognitive Dysfunction Concussion Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Down Syndrome Dyskinesias Frontotemporal Dementia Frontotemporal Lobar Degeneration Genetic Diseases, Inborn Head Injuries, Closed Heredodegenerative Disorders, Nervous System Huntington Disease Immune System Diseases Intellectual Disability Lewy Body Dementia Lewy Body Disease Mental Disorders Metabolic Diseases Mild Cognitive Impairment Motor Neuron Disease Movement Disorders Multiple Sclerosis Nervous System Diseases Neuro-Degenerative Disease Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Normal Cognition Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Post-traumatic Stress Disorder Proteostasis Deficiencies Spinal Cord Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Synucleinopathies TDP-43 Proteinopathies Tauopathies Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Sharon Fekrat, MD FACS FASRS

CONTACT

[email protected]

919-681-3937

About this study

Using a multidisciplinary approach, this study aims to yield new insight into the vascular and structural pathophysiology of neurodegenerative disease. The investigators propose to develop and evaluate imaging biomarkers from OCT, OCTA, and UWF fundus photos to assess the structure and function of the retinal and choroidal microvasculature and structure in these individuals.

The investigators hypothesize that microvascular and structural network alterations in the retina and choroid may mirror and possibly precede changes in the cerebral microcirculation seen in these neurodegenerative diseases. Using advanced image analysis and machine learning techniques, the investigators aim to evaluate markers of reduced capillary blood flow and non-perfusion in the superficial retinal vascular plexus and choriocapillaris imaged using OCT and OCTA, in a resolution not previously possible, that would complement already established retinal structural markers and increase their sensitivity and specificity in the earlier detection of these neurodegenerative diseases.

This study looks to provide a proof of concept for retinal and choroidal imaging-based microvascular and structural biomarkers as an effective screening tool for neurodegenerative disease, particularly during in cognitive aging.

The protocol for this study was amended and the record was updated accordingly.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

If two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.

Treatment and study plan

Retinal and Choroidal Imaging

Device

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

Primary outcomes

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

    Time frame: Baseline, 1 year

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

  2. Change in retinal nerve fiber layer (RNFL) thickness

    Time frame: Baseline, 1 year

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

  3. Change in central subfield thickness (CST)

    Time frame: Baseline, 1 year

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

  4. Change in choroidal vascularity index (CVI)

    Time frame: Baseline, 1 year

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

  5. Change in foveal avascular zone (FAZ) area

    Time frame: Baseline, 1 year

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

  6. Change in average perfusion density (PD)

    Time frame: Baseline, 1 year

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

  7. Change in average vessel density (VD)

    Time frame: Baseline, 1 year

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

  8. Change in average capillary perfusion density (CPD)

    Time frame: Baseline, 1 year

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

  9. Change in average capillary flux index (CFI)

    Time frame: Baseline, 1 year

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

Secondary outcomes

  1. Change in retinal vessel tortuosity

    Time frame: Baseline, 1 year

    Retinal vessel tortuosity measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software

  2. Change in retinal vessel width gradient

    Time frame: Baseline, 1 year

    Retinal vessel width gradient measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software

  3. Change in retinal vessel fractal dimension

    Time frame: Baseline, 1 year

    Retinal vessel fractal dimension measured on ultra-widefield scanning laser ophthalmoscopy image using VAMPIRE software

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Fekrat, MD FACS FASRS

CONTACT

[email protected]

919-681-3937

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Queens University of Belfast United Kingdom
  • Tan Tock Seng Hospital in Singapore
  • University of Edinburgh in Scotland

Registry information

Official study title

Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2017
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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