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OpenTrials
Completed

NCT Number: NCT04567745

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retinal fundus photography

Diagnostic Test

Fundus photographs

Primary outcomes

  1. retinopathy features identification

    Time frame: 12 months

    The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Eyenuk, Inc.
  • Kaushal Solanki
  • Malavika Bhaskaranand PhD

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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