Health TrialsbyHealthPanel

Retinal Imaging in Neurodegenerative Disease

ConditionsAlzheimer's DiseaseMild Cognitive ImpairmentParkinson's DiseaseMultiple SclerosisHuntington DiseaseLewy Body DementiaFrontotemporal DementiaAmyotrophic Lateral Sclerosis (ALS)APOE-4 PositiveTraumatic Brain InjuryConcussionPost-Traumatic Stress DisorderDown SyndromeNeuro-Degenerative DiseaseNormal Cognition
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Neurology Clinics and the community.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Retinal and Choroidal Imaging

    Device

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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Case1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Baseline, 1 year
2

Change in retinal nerve fiber layer (RNFL) thickness

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

Time frame
Baseline, 1 year
3

Change in central subfield thickness (CST)

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

Time frame
Baseline, 1 year
4

Change in choroidal vascularity index (CVI)

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

Time frame
Baseline, 1 year

Secondary outcomes

1

Change in retinal vessel tortuosity

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

Time frame
Baseline, 1 year
2

Change in retinal vessel width gradient

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

Time frame
Baseline, 1 year
3

Change in retinal vessel fractal dimension

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

Time frame
Baseline, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

University of Edinburgh in Scotland

Collaborator

Tan Tock Seng Hospital in Singapore

Collaborator

Queens University of Belfast United Kingdom

Collaborator

Source ClinicalTrials.gov
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