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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963441
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
IDx LLC

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Diabetic Retinopathy
Enrollment 900
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Intent to Screen Population
Hide Arm/Group Description Prospective study participants
Period Title: Overall Study
Started 900
Completed 819
Not Completed 81
Reason Not Completed
Protocol violation or withdrawn             8
Ungradeable by FPRC or IDx             40
IDx-DR insufficient quality             33
Arm/Group Title Effective Analysis Population
Hide Arm/Group Description All subjects with a reading center reference standard and AI output (population that is available for statistical analysis).
Overall Number of Baseline Participants 819
Hide Baseline Analysis Population Description
Number of analyzable study participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Age (years) Number Analyzed 819 participants
<=18 years
0
   0.0%
Between 18 and 65 years
566
  69.1%
>=65 years
253
  30.9%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 819 participants
Male
389
  47.5%
Female
430
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 819 participants
Hispanic or Latino
134
  16.4%
Not Hispanic or Latino
680
  83.0%
Unknown or Not Reported
5
   0.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 819 participants
American Indian or Alaska Native
3
   0.4%
Asian
12
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
231
  28.2%
White
523
  63.9%
More than one race
10
   1.2%
Unknown or Not Reported
40
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 819 participants
819
1.Primary Outcome
Title Sensitivity Corrected for Enrichment
Hide Description Sensitivity corrected for enrichment using logistic regression
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Analyzable Study Population
Hide Arm/Group Description:
Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Overall Number of Participants Analyzed 819
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true positives
87.2
(81.8 to 91.2)
2.Primary Outcome
Title Specificity Corrected for Enrichment
Hide Description Specificity corrected for enrichment using logistic regression
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Analyzable Study Population
Hide Arm/Group Description:
Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Overall Number of Participants Analyzed 819
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true negatives
90.7
(88.3 to 92.7)
3.Primary Outcome
Title Observed Sensitivity
Hide Description The sensitivity observed without adjustment by logistic regression
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Analyzable Study Population
Hide Arm/Group Description:
Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Overall Number of Participants Analyzed 819
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true positives
87.4
(81.9 to 92.9)
4.Primary Outcome
Title Observed Specificity
Hide Description The specificity observed without adjustment by logistic regression
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Analyzable Study Population
Hide Arm/Group Description:
Participants that had reading center grading and AI disease outputs that were available for statistical analysis.
Overall Number of Participants Analyzed 819
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true negatives
89.5
(86.9 to 93.1)
5.Primary Outcome
Title Sufficient vs. Insufficient Image Quality Output From IDx-DR
Hide Description 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)
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Image-ability, defined as the percentage of participants with a completed FPRC grading and a disease level IDx-DR output
Arm/Group Title Analyzable Study Population
Hide Arm/Group Description:
Participants with the reading center results needed for study analysis.
Overall Number of Participants Analyzed 852
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.1
(94.0 to 96.8)
Time Frame Adverse events were collected from Day 1 to 30 days after last study contact.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enrolled Population
Hide Arm/Group Description All study subjects enrolled into the clinical study.
All-Cause Mortality
Enrolled Population
Affected / at Risk (%)
Total   0/900 (0.00%)    
Hide Serious Adverse Events
Enrolled Population
Affected / at Risk (%) # Events
Total   0/900 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled Population
Affected / at Risk (%) # Events
Total   5/900 (0.56%)    
Eye disorders   
Eye edema * [1]  1/900 (0.11%)  1
Vision blurred *  1/900 (0.11%)  1
Eye irritation * [2]  1/900 (0.11%)  1
Metabolism and nutrition disorders   
Hypoglycemic Episode *  1/900 (0.11%)  1
Nervous system disorders   
Headache *  1/900 (0.11%)  1
Psychiatric disorders   
Panic attack * [3]  1/900 (0.11%)  1
Vascular disorders   
Hypotension *  1/900 (0.11%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Bilateral swelling in eyes post dilation
[2]
burning sensation
[3]
symptoms occurred after eye drops instilled
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: IDx President, Dr. Michael Abramoff
Organization: IDx LLC
Phone: 319-248-5620
EMail: info@eyediagnosis.net
Layout table for additonal information
Responsible Party: IDx LLC
ClinicalTrials.gov Identifier: NCT02963441    
Other Study ID Numbers: IDx-DR1
First Submitted: November 10, 2016
First Posted: November 15, 2016
Results First Submitted: October 2, 2018
Results First Posted: May 28, 2021
Last Update Posted: May 28, 2021