Trial Outcomes & Findings for A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus (NCT NCT04160988)

Results Overview

To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)

Recruitment status

COMPLETED

Target enrollment

703 participants

Primary outcome timeframe

2 months

Results posted on

2021-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population.
Overall Study STARTED	703
Overall Study COMPLETED	675
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Group A total of 703 subjects with at least one qualified color fundus photography image as determined by the ophthalmologist were enrolled in this study. All 703 subjects enrolled were included in the intended use population. A total of 703 qualified color fundus photography images from all enrolled subjects were included for effectiveness analysis. No subjects were excluded from the intended use population.
Overall Study poor image quality	28

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Use Population n=703 Participants Intended Use Population
Age, Continuous	58.5 years STANDARD_DEVIATION 13.6 • n=703 Participants
Sex: Female, Male Female	354 Participants n=703 Participants
Sex: Female, Male Male	349 Participants n=703 Participants
Region of Enrollment Taiwan	703 Participants n=703 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)

Outcome measures

Outcome measures
Measure	Intended Use Population n=675 Participants Intended Use Population
Sensitivity	95 percent Interval 92.48 to 96.82

PRIMARY outcome

Timeframe: 2 months

Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)

Outcome measures

Outcome measures
Measure	Intended Use Population n=675 Participants Intended Use Population
Specificity	89.9 percent Interval 85.37 to 96.43

SECONDARY outcome

Timeframe: 2 months

Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee DR by determining the positive predictive values (PPV). Positive predictive value (PPV) =100% x TP/(TP+FP)

Outcome measures

Outcome measures
Measure	Intended Use Population n=675 Participants Intended Use Population
Positive Predictive Values (PPV)	94.5 percent Interval 91.97 to 96.47

SECONDARY outcome

Timeframe: 2 months

Population: Of 703 subjects enrolled, VeriSee DR judged the images of 28 subjects (3.98%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee DR by determining the negative predictive values (NPV). Negative predictive value (NPV) = 100% x TN/(FN+TN)

Outcome measures

Outcome measures
Measure	Intended Use Population n=675 Participants Intended Use Population
Negative Predictive Values (NPV)	90.7 percent Interval 86.23 to 94.07

SECONDARY outcome

Timeframe: 2 months

To determine the percentage of subjects' images with insufficient quality as judged by VeriSee DR. The percentage of subjects who have the images with insufficient quality as determined by VeriSee DR will be presented.

Outcome measures

Outcome measures
Measure	Intended Use Population n=703 Participants Intended Use Population
Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR	28 Participants

Adverse Events

Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Regulator Manager

Acer Healthcare Inc.

Phone: 886-6-26963131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place