Trial Outcomes & Findings for Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images (NCT NCT04612868)
NCT ID: NCT04612868
Last Updated: 2023-08-01
Results Overview
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.
COMPLETED
NA
531 participants
1 day
2023-08-01
Participant Flow
Participant milestones
| Measure |
AEYE Software Device
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.
AEYE Software Device: 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.
|
|---|---|
|
Overall Study
STARTED
|
531
|
|
Overall Study
Analyzable
|
468
|
|
Overall Study
COMPLETED
|
462
|
|
Overall Study
NOT COMPLETED
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Baseline characteristics by cohort
| Measure |
AEYE Software Device
n=468 Participants
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.
AEYE Software Device: 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.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
246 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
329 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
323 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
440 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Completed subjects with valid ground truth and AEYE-DS results
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.
Outcome measures
| Measure |
AEYE Software Device
n=462 Participants
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.
AEYE Software Device: 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.
|
|---|---|
|
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Sensitivity
|
92.98 percentage of participants
Interval 83.3 to 97.24
|
|
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
Specificity
|
91.36 percentage of participants
Interval 88.22 to 93.72
|
SECONDARY outcome
Timeframe: 1 dayPopulation: completed subjects with valid ground truth and AEYE-DS results
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.
Outcome measures
| Measure |
AEYE Software Device
n=462 Participants
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.
AEYE Software Device: 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.
|
|---|---|
|
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
Sensitivity
|
94.74 percentage of participants
Interval 85.63 to 98.19
|
|
Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
Specificity
|
88.64 percentage of participants
Interval 85.18 to 91.38
|
SECONDARY outcome
Timeframe: 1 dayTo 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.
Outcome measures
| Measure |
AEYE Software Device
n=462 Participants
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.
AEYE Software Device: 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.
|
|---|---|
|
Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
|
99.1 percentage of participants
Interval 97.8 to 99.7
|
SECONDARY outcome
Timeframe: 1 dayTo 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.
Outcome measures
| Measure |
AEYE Software Device
n=462 Participants
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.
AEYE Software Device: 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.
|
|---|---|
|
Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)
|
99.1 percentage of participants
Interval 97.8 to 99.7
|
Adverse Events
AEYE Software Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place