N/A
Completed N=531
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Source: ClinicalTrials.gov NCT04612868 ↗Enrolled (actual)
531
Serious AEs
—
Results posted
Aug 2023
Primary outcomePrimary: Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient) — 92.98; 91.36 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient) |
92.98; 91.36 | — |
| SECONDARY Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye) |
94.74; 88.64 | — |
| SECONDARY Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient) |
99.1 | — |
| SECONDARY Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye) |
99.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04612868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.