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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT04567745
• Collaborator: Eyenuk, Inc. (Industry), Malavika Bhaskaranand PhD (Other), Kaushal Solanki (Other)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Alzheimer Disease; Vascular Dementia	Diagnostic Test: Retinal fundus photography	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline
• Actual Study Start Date: Sep 29, 2020
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Cognitive diagnosis	Diagnostic Test: Retinal fundus photography; Fundus photographs

Outcome Measures

Primary Outcome Measures

1. retinopathy features identification [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Oana Dumitrascu, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Oana M. Dumitrascu, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04567745
• Other Study ID Numbers: 20-007289
• First Posted: Sep 28, 2020
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alzheimer Disease; Dementia, Vascular; Cognitive Dysfunction

Study Results

No Results Posted as of Nov 1, 2021