22 and older, any sex, with Diabetes Mellitus or Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)Primary· 1 day
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.
Sensitivity
Group
Value
95% CI
AEYE Software Device
92.98
83.3 – 97.24
Specificity
Group
Value
95% CI
AEYE Software Device
91.36
88.22 – 93.72
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)Secondary· 1 day
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.
Sensitivity
Group
Value
95% CI
AEYE Software Device
94.74
85.63 – 98.19
Specificity
Group
Value
95% CI
AEYE Software Device
88.64
85.18 – 91.38
Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)Secondary· 1 day
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.
Group
Value
95% CI
AEYE Software Device
99.1
97.8 – 99.7
Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)Secondary· 1 day
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.
Group
Value
95% CI
AEYE Software Device
99.1
97.8 – 99.7
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other AEYE Health Inc trials
Trials by the same sponsor.
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Sponsor: as reported to ClinicalTrials.gov by AEYE Health Inc
Last refreshed: 1 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04612868.