Retinal Imaging in Neurodegenerative Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retinal and Choroidal Imaging.
- Who it may be relevant to
- Registry conditions: Alzheimer's Disease, Mild Cognitive Impairment, Parkinson's Disease, Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study
Overview
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.
Interventions
- Device Retinal and Choroidal Imaging
Non-invasive OCT, OCTA, and UWF fundus photography of retina
Primary outcome measures
- Change in ganglion cell-inner plexiform layer (GCIPL) thickness [Time frame: Baseline, 1 year]
- Change in retinal nerve fiber layer (RNFL) thickness [Time frame: Baseline, 1 year]
- Change in central subfield thickness (CST) [Time frame: Baseline, 1 year]
- Change in choroidal vascularity index (CVI) [Time frame: Baseline, 1 year]
- Change in foveal avascular zone (FAZ) area [Time frame: Baseline, 1 year]
- Change in average perfusion density (PD) [Time frame: Baseline, 1 year]
- Change in average vessel density (VD) [Time frame: Baseline, 1 year]
- Change in average capillary perfusion density (CPD) [Time frame: Baseline, 1 year]
- Change in average capillary flux index (CFI) [Time frame: Baseline, 1 year]
Secondary outcome measures (3)
- Change in retinal vessel tortuosity [Time frame: Baseline, 1 year]
- Change in retinal vessel width gradient [Time frame: Baseline, 1 year]
- Change in retinal vessel fractal dimension [Time frame: Baseline, 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Publications
- 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
- 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
Identifiers
NCT: NCT03233646 · Pro00111831