Back to resultsEfficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Primary Purpose
Diabetes Mellitus, Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AEYE Software Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- The Eye Care Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AEYE Software Device
Arm Description
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.
Outcomes
Primary Outcome Measures
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
Secondary Outcome Measures
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
Sensitivity and specificity of the AEYE-DS device to detect mtmDR from digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on four images (one macula centered image and one optic disc centered image per eye). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.
Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04612868
Brief Title
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Official Title
Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2020 (Actual)
Primary Completion Date
November 28, 2021 (Actual)
Study Completion Date
December 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEYE Health LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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 fundus images using Artificial Intelligence (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
531 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AEYE Software Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AEYE Software Device
Intervention Description
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 Optical Coherence Tomography (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.
Primary Outcome Measure Information:
Title
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Description
Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
Description
Sensitivity and specificity of the AEYE-DS device to detect mtmDR from digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on four images (one macula centered image and one optic disc centered image per eye). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
Time Frame
1 day
Title
Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Description
To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.
Time Frame
1 day
Title
Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
Description
To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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 Diabetic Retinopathy (DR) or Diabetic Macular Edema (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
Facility Information:
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
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