ARDA Software for the Detection of mtmDR
A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
1 other identifier
observational
1,012
1 country
13
Brief Summary
This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
September 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2022
CompletedJune 6, 2022
June 1, 2022
8 months
May 24, 2021
June 1, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Sensitivity of ARDA mtmDR for detection of mtmDR in 45 degree images
1 day
Specificity of ARDA mtmDR for detection of mtmDR in 45 degree images
1 day
Sensitivity of ARDA mtmDR for detection of mtmDR in UWF images
1 day
Specificity of ARDA mtmDR for detection of mtmDR in UWF images
1 day
Study Arms (1)
Retinal Imaging and Mydriatic Agents
Subjects will undergo several types of retinal imaging before and after administration of mydriatic agent. Subjects will be administered mydriatic medication to dilate their pupils.
Interventions
Subject images will be sent to the investigational ARDA software
Eligibility Criteria
Sites in the U.S.
You may qualify if:
- Documented diagnosis of Type I or Type II diabetes mellitus:
- meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
- Age 22 or older
- Understand the study and volunteer to sign the informed consent
You may not qualify if:
- Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
- Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
- History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
- Currently participating in an interventional study.
- Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
- Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
- Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
- Participant has undergone photodynamic therapy (PDT)
- Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
- Known pregnancy or possibility of pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Verily Life Sciences LLClead
- Google LLC.collaborator
- Optos, PLCcollaborator
- Nikon Corporationcollaborator
- The Emmes Company, LLCcollaborator
Study Sites (13)
Midwestern University
Glendale, Arizona, 85308, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72404, United States
Catalina Research Institute
Montclair, California, 91763, United States
Christie Clinic
Champaign, Illinois, 61822, United States
Northwestern University
Chicago, Illinois, 60611, United States
MedStar Health Research Institute Baltimore
Baltimore, Maryland, 21239, United States
Riverside Diabetes Clinic
Riverdale, Maryland, 20737, United States
Western Michigan University
Kalamazoo, Michigan, 49008, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, 27103, United States
Diabetes & Endocrinology Associates of Stark County, Inc
Canton, Ohio, 44718, United States
The Heart and Medical Center, P.C
Durant, Oklahoma, 74701, United States
BMG The Endocrine Clinic
Memphis, Tennessee, 38119, United States
Clinical Trials Network
Houston, Texas, 77074, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2021
First Posted
May 27, 2021
Study Start
September 30, 2021
Primary Completion
May 23, 2022
Study Completion
May 23, 2022
Last Updated
June 6, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share