NCT03233646 · Duke University
Retinal Imaging in Neurodegenerative Disease
What this study is about
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.
View original scientific description
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.
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
Ganglion cell inner plexiform layer thickness as measured on optical coherence tomography scan of macula
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
Change in central subfield thickness (CST)
Time frame: Baseline, 1 year
Central subfield thickness as measured on optical coherence tomography scan of macula
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
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
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
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
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
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Durham, North Carolina
Collaborators
University of Edinburgh in Scotland, Tan Tock Seng Hospital in Singapore, Queens University of Belfast United Kingdom
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 4, 2026 · Source of record for eligibility and locations