Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images

Study Overview
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Brief Summary
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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.

Official Title
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Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images

Conditions
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Diabetes Mellitus, Diabetic Retinopathy

Intervention / Treatment
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* Device: AEYE Software Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEYE Software Device<br>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 Software Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 
| 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. | 1 day | 
| 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. | 1 day |