Clinical trial NCT03233646: Retinal Imaging in Neurodegenerative Disease
Official title: Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Edinburgh in Scotland
name: Tan Tock Seng Hospital in Singapore
name: Queens University of Belfast United Kingdom
First posted: 2017-07-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology Clinics and the community.

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in ganglion cell-inner plexiform layer (GCIPL) thickness
timeFrame: Baseline, 1 year
measure: Change in retinal nerve fiber layer (RNFL) thickness
timeFrame: Baseline, 1 year
measure: Change in central subfield thickness (CST)
timeFrame: Baseline, 1 year
measure: Change in choroidal vascularity index (CVI)
timeFrame: Baseline, 1 year
measure: Change in foveal avascular zone (FAZ) area
timeFrame: Baseline, 1 year
measure: Change in average perfusion density (PD)
timeFrame: Baseline, 1 year
measure: Change in average vessel density (VD)
timeFrame: Baseline, 1 year
measure: Change in average capillary perfusion density (CPD)
timeFrame: Baseline, 1 year
measure: Change in average capillary flux index (CFI)
timeFrame: Baseline, 1 year
Secondary outcomes:
measure: Change in retinal vessel tortuosity
timeFrame: Baseline, 1 year
measure: Change in retinal vessel width gradient
timeFrame: Baseline, 1 year
measure: Change in retinal vessel fractal dimension
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sharon Fekrat, MD FACS FASRS
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Dilraj Grewal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.