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

Phase 1

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer Disease; Vascular Dementia
• Interventions: Diagnostic Test: Retinal fundus photography

• Registration Number: NCT04567745
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2020-09-29
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive diagnosis	Retinal fundus photography	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States