Trial Outcomes & Findings for Clinical Evaluation of VeriSee AMD in Screening for Age-Related Macular Degeneration (NCT NCT05593913)

NCT ID: NCT05593913

Last Updated: 2024-01-22

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 986 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2024-01-22

Participant Flow

Participant milestones

Measure	Test Group The 986 subjects from the intended population, having at least one qualified color fundus photography image determined by the ophthalmologist, were enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use for effectiveness analysis.
Overall Study STARTED	986
Overall Study COMPLETED	947
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Measure	Test Group The 986 subjects from the intended population, having at least one qualified color fundus photography image determined by the ophthalmologist, were enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use for effectiveness analysis.
Overall Study Insufficient image quality	39

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Test Group n=986 Participants The 986 subjects from the intended patient population, having at least one qualified color fundus photography image determined by the ophthalmologist, enrolled in this study. A total of 986 color fundus photography images from all enrolled subjects were in use for effectiveness analysis.
Age, Continuous	69.6 years STANDARD_DEVIATION 11.23 • n=986 Participants
Sex: Female, Male Female	403 Participants n=986 Participants
Sex: Female, Male Male	583 Participants n=986 Participants
Region of Enrollment Taiwan	986 Participants n=986 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee AMD by determining the sensitivity.

Sensitivity = 100% x TP/(TP+FN)

Outcome measures

Measure	Test Group n=947 Participants Intended Use Population
Sensitivity	90 percent Interval 85.05 to 93.67

PRIMARY outcome

Timeframe: 1 day

Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as insufficient image quality.

To evaluate the clinical performance of VeriSee AMD by determining the Specificity.

Specificity = 100% x TN/(TN+FP)

Outcome measures

Measure	Test Group n=947 Participants Intended Use Population
Specificity	96.5 percent Interval 94.88 to 97.69

SECONDARY outcome

Timeframe: 1 day

Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee AMD by determining the positive predictive values (PPV).

Positive predictive value (PPV) =100% x TP/(TP+FP)

Outcome measures

Measure	Test Group n=947 Participants Intended Use Population
Positive Predictive Values (PPV)	87.9 percent Interval 82.71 to 91.91

SECONDARY outcome

Timeframe: 1 day

Population: Of 986 subjects enrolled, VeriSee AMD judged the images of 39 subjects (3.96%) as with insufficient image quality.

To evaluate the clinical performance of VeriSee AMD by determining the negative predictive values (NPV).

Negative predictive value (NPV) = 100% x TN/(FN+TN)

Outcome measures

Measure	Test Group n=947 Participants Intended Use Population
Negative Predictive Values (NPV)	97.1 percent Interval 95.65 to 98.22

SECONDARY outcome

Timeframe: 1 day

Population: The enrolled subjects

The percentage of the images with insufficient quality as determined by VeriSee AMD will be presented.

Outcome measures

Measure	Test Group n=986 Participants Intended Use Population
The Percentage of Subjects' Images With Insufficient Quality as Judged by VeriSee AMD	39 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 Medical Inc.

Phone: 886-2-26960366

Email: AcerMedicalofficial@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place