Recruiting

Retinal Imaging

Sponsor:

Duke University

Code:

NCT03233646

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Parkinson's Disease

Multiple Sclerosis

Huntington Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Retinal and Choroidal Imaging

Study Details

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.

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Parkinson's Disease

Multiple Sclerosis

Huntington Disease

Study ID

NCT03233646

Start date

Jul 20, 2017

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Case

Patients with (MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)

Controls

Controls will be recruited from the relatives/attendants of study participants or will be patients themselves and will not have a neurodegenerative disease diagnosis.

Interventions

Retinal and Choroidal Imaging

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Sharon Fekrat, MD FACS FASRS

919-681-3937imind@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Sharon Fekrat, MD FACS FASRS

919-681-3937imind@duke.edu

More Information

Sponsor

Duke University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Duke University on 2026-02-04.