Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers

Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04567745

Enrollment

Registered

2020-09-28

Start date

2020-09-29

Completion date

2021-09-30

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia

Brief summary

This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer's disease, and vascular dementia.

Interventions

DIAGNOSTIC_TESTRetinal fundus photography

Fundus photographs

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).

Exclusion criteria

* Children and subjects with other diagnoses than those mentioned in the inclusion criteria. * Patients without the means to visit the clinic on the assigned dates. * Patients who are pregnant or are expecting to become pregnant.

Design outcomes

Primary

Measure	Time frame	Description
retinopathy features identification	12 months	The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026