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Pivotal Trial to Assess the Clinical Performance of Ophthal-360 for the Detection of Diabetic Retinopathy

NCT05806957 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-04-10

No results posted yet for this study

Summary

Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.

Conditions

Interventions

DEVICE

Fundus Photography

Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT

Sponsors & Collaborators

  • Ophthalytics, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-09-01
Completion
2024-09-30
FDA Device
Yes

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Entities

Diseases

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 NCT05806957 on ClinicalTrials.gov