NCT05857943

Brief Summary

AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

March 29, 2023

Last Update Submit

November 7, 2023

Conditions

Diabetes MellitusDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity

    1 year

Study Arms (1)

AEYE-DS Software Device

EXPERIMENTAL

An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy

Device: AEYE-DS Software

Interventions

AEYE-DS SoftwareDEVICE

Eligible participants will undergo the following procedures: Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis. -Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis. -All study subjects will have their pupils dilated using dilation drops.

AEYE-DS Software Device

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥22
  • Male or female
  • Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
  • Understand the study and volunteer to sign the informed consent

You may not qualify if:

  • Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
  • Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
  • Previously diagnosed with Diabetic Retinopathy.
  • History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
  • Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
  • Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
  • Participant is contraindicated for imaging by fundus imaging systems used in the study:
  • Participant is hypersensitive to light
  • Participant recently underwent photodynamic therapy (PDT)
  • Participant is taking medication that causes photosensitivity
  • Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
  • Subject is pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karas Health Care

Fayetteville, Arkansas, 72701, United States

Location

Lake Nona Research

Orlando, Florida, 32832, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 15, 2023

Study Start

March 29, 2023

Primary Completion

September 11, 2023

Study Completion

October 10, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)