OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases (OPHTAI-EVAL)

September 25, 2023 updated by: Evolucare Technologies

Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OphtAI-Eval: is a prospective, multicentre, post-marketing clinical follow-up study (SCAC) of diagnostic validation (comparative vs gold standard).

It aims to: validate the diagnostic performance of the OphtAI software for the automated screening of diabetic retinopathy, diabetic macular edema, glaucoma, ARM and AMD.

Evolucare OphtAI is a medical imaging console for ophthalmology, interfaced with Evolucare Imaging.

It allows the detection, by statistical learning algorithms, of the following ocular pathologies using photographs of the retina:

  • Diabetic retinopathy (DR) (including gradation),
  • Diabetic macular edema (DME)
  • Age-related macular degeneration (AMD)
  • Age-related maculopathy (ARM, early form of AMD),
  • Glaucoma.

Evolucare OphtAI, is available on the French market since March 2019.

Study Type

Interventional

Enrollment (Estimated)

1389

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Doesn't not accept healthy volunteers as diabetic patients are needed, still they may be free of any eye diseases.

Inclusion Criteria:

The characteristics required for a subject to take part in the research are

  • Male or female over 18,
  • Type 1 or 2 diabetic,
  • Presenting for screening for diabetic retinopathy,
  • Beneficiary of a social security scheme,
  • For whom written consent has been obtained for participation in the protocol.

Exclusion Criteria:

The following characteristics do not allow the subject to take part in the research:

  • Patient with known DR, more severe than "minimal", including having been treated,
  • Any other condition that, in the opinion of the health professionals, may interfere with their ability to complete the study or may present a significant risk,
  • Presence of social, medical and/or psychological factors that may compromise the patient's adherence to the protocol,
  • Simultaneously participating in another clinical research protocol or having recently participated in another research study for which the exclusion period would not be completed.

Patients who participate in this research will not be able to participate in another research at the same time. However, there is no exclusion period at the end of this research for participation in any other study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diabetic patient group assessed for multiple eye diseases
Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referable Diabetic Retinopathy screening sensitivity/specificity
Time Frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetic retinopathy grading sensitivity/specificity
Time Frame: 1 year
Diabetic retinopathy grading performance (OphtAI software vs Expert reader) for each grading sub algorithms (sensitivity/specificity) and globally (accuracy/agreement ratio)
1 year
Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection
Time Frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RD grading algorithms combination
1 year
Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection
Time Frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full and RD grading algorithms combination
1 year
Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection
Time Frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha, RD grading and DME algorithms combination
1 year
Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection
Time Frame: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full , RD grading and DME algorithms combination
1 year
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
Time Frame: 1 year
Diabetic Macular Edema screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for DME algorithm
1 year
Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection
Time Frame: 1 year
AMD screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for AMD algorithm, for all forms and for either atrophic or neovascular AMD
1 year
Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection
Time Frame: 1 year
ARM screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for ARM algorithm, for all forms and for either macular or peripheric drusen, or for either hard/soft drusen
1 year
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
Time Frame: 1 year
Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms
1 year
Quality algorithm accuracy for quality assessment
Time Frame: 1 year
Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms
1 year
Laterality determination algorithm accuracy for laterality assessment
Time Frame: 1 year
Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evolucare Technologies

Collaborators

Assistance Publique - Hôpitaux de Paris
Slb Pharma
BPIfrance

Investigators

  • Principal Investigator: Aude Couturier, Dr, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01813-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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