Trial Outcomes & Findings for A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy (NCT NCT02963441)

NCT ID: NCT02963441

Last Updated: 2024-03-07

Results Overview

Sensitivity corrected for enrichment using logistic regression

• Recruitment status: COMPLETED
• Target enrollment: 900 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2024-03-07

Participant Flow

From January 2017 to July 2017, 900 participants were prospectively enrolled in this observational study at 10 primary care practice sites throughout the United States.

Participant milestones

Measure	Intent to Screen Population Prospective study participants
Overall Study STARTED	900
Overall Study COMPLETED	819
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Measure	Intent to Screen Population Prospective study participants
Overall Study Protocol violation or withdrawn	8
Overall Study Ungradeable by FPRC or IDx	40
Overall Study IDx-DR insufficient quality	33

Baseline Characteristics

A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy

Baseline characteristics by cohort

Measure	Effective Analysis Population n=819 Participants All subjects with a reading center reference standard and AI output (population that is available for statistical analysis).
Age, Categorical Age (years) · <=18 years	0 Participants n=5 Participants
Age, Categorical Age (years) · Between 18 and 65 years	566 Participants n=5 Participants
Age, Categorical Age (years) · >=65 years	253 Participants n=5 Participants
Sex/Gender, Customized Male	389 Participants n=5 Participants
Sex/Gender, Customized Female	430 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	134 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	680 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	12 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	231 Participants n=5 Participants
Race (NIH/OMB) White	523 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants
Region of Enrollment United States	819 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Sensitivity corrected for enrichment using logistic regression

Outcome measures

Measure	Analyzable Study Population n=819 Participants Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Sensitivity Corrected for Enrichment	87.2 percentage of true positives Interval 81.8 to 91.2

PRIMARY outcome

Timeframe: Day 1

Specificity corrected for enrichment using logistic regression

Outcome measures

Measure	Analyzable Study Population n=819 Participants Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Specificity Corrected for Enrichment	90.7 percentage of true negatives Interval 88.3 to 92.7

PRIMARY outcome

Timeframe: Day 1

The sensitivity observed without adjustment by logistic regression

Outcome measures

Measure	Analyzable Study Population n=819 Participants Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Observed Sensitivity	87.4 percentage of true positives Interval 81.9 to 92.9

PRIMARY outcome

Timeframe: Day 1

The specificity observed without adjustment by logistic regression

Outcome measures

Measure	Analyzable Study Population n=819 Participants Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Observed Specificity	89.5 percentage of true negatives Interval 86.9 to 93.1

PRIMARY outcome

Timeframe: Day 1

Population: Image-ability, defined as the percentage of participants with a completed FPRC grading and a disease level IDx-DR output

Image-ability, defined as the percentage of participants with a completed reading center grading and a disease level output from the investigational device (IDx-DR)

Outcome measures

Measure	Analyzable Study Population n=852 Participants Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Sufficient vs. Insufficient Image Quality Output From IDx-DR	96.1 percentage of participants Interval 94.0 to 96.8

Adverse Events

Enrolled Population

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enrolled Population n=900 participants at risk All study subjects enrolled into the clinical study.
Psychiatric disorders Panic attack	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Metabolism and nutrition disorders Hypoglycemic Episode	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Eye disorders Eye edema	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Vascular disorders Hypotension	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Eye disorders Vision blurred	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Eye disorders Eye irritation	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.
Nervous system disorders Headache	0.11% 1/900 • Number of events 1 • Adverse events were collected from Day 1 to 30 days after last study contact.

Additional Information

IDx President, Dr. Michael Abramoff

IDx LLC

Phone: 319-248-5620

Email: info@eyediagnosis.net

Results disclosure agreements

• Principal investigator is a sponsor employee If a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study, Institution will be free to publish the methods, data and results of the Study
• Publication restrictions are in place

Restriction type: OTHER