OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

NCT05752045 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1389

Last updated 2023-09-28

No results posted yet for this study

Summary

Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.

Conditions

Interventions

DEVICE

Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device

Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER
  • BPIfrance

    collaborator OTHER
  • Evolucare Technologies

    lead INDUSTRY

Principal Investigators

  • Aude Couturier, Dr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-28
Primary Completion
2023-10-31
Completion
2024-03-31

Countries

  • France

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 NCT05752045 on ClinicalTrials.gov