Camera Qualification Study

NCT05808699 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 626

Last updated 2024-10-22

No results posted yet for this 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.

Conditions

Interventions

DEVICE

handheld fundus camera

Fundus camera

Sponsors & Collaborators

  • Laboratory Corporation of America

    collaborator INDUSTRY
  • Digital Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Abramnoff, MD, PhD · Digital Diagnostics, Inc.

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2023-11-30
Completion
2025-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808699 on ClinicalTrials.gov