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Diagnostic Device

Fundus camera image for Diabetic Retinopathy

N/A
Waitlist Available
Research Sponsored by Digital Diagnostics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~1-month after day 1
Awards & highlights

Study Summary

A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~1-month after day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~1-month after day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity and Specificity Corrected for Enrichment
Secondary outcome measures
Observed Sensitivity and Specificity, Level II
Other outcome measures
Precision substudy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fundus camera imageExperimental Treatment1 Intervention
Subjects imaged with a fundus camera

Find a Location

Who is running the clinical trial?

FortreaUNKNOWN
9 Previous Clinical Trials
1,855 Total Patients Enrolled
Digital Diagnostics, Inc.Lead Sponsor
4 Previous Clinical Trials
2,593 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
2,593 Patients Enrolled for Diabetic Retinopathy
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,320 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Camera Qualification Study
2023. "Camera Qualification Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05808699.
All > Fargo
~271 spots leftby Apr 2025
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