Clinical trial NCT05752045: OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Official title: Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Age-Related Macular Degeneration
Age-related Maculopathy
Glaucoma
Keywords: OphtAI
Artificial intelligence
Computer-aided diagnosis
Automated screening
Medical Device
Diabetic patient
Diabetic Retinopathy
Diabetic Macular Edema
Age-Related Macular Degeneration
Age-related Maculopathy
Glaucoma
Evolucare OphtAI
Lead sponsor: Evolucare Technologies
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
name: Assistance Publique - Hôpitaux de Paris
name: BPIfrance
First posted: 2023-03-02
Enrollment: 1389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Imaging and clinical data will be collected from patients to be reviewed by an expert reader group providing ground truth, and the medical device will be tested against this ground truth
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Referable Diabetic Retinopathy screening sensitivity/specificity
timeFrame: 1 year
Secondary outcomes:
measure: Diabetic retinopathy grading sensitivity/specificity
timeFrame: 1 year
measure: Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection
timeFrame: 1 year
measure: Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection
timeFrame: 1 year
measure: Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection
timeFrame: 1 year
measure: Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection
timeFrame: 1 year
measure: Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
timeFrame: 1 year
measure: Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection
timeFrame: 1 year
measure: Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection
timeFrame: 1 year
measure: Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
timeFrame: 1 year
measure: Quality algorithm accuracy for quality assessment
timeFrame: 1 year
measure: Laterality determination algorithm accuracy for laterality assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Aix Vision
city: Brest
country: France
facility: CHU Brest
city: Brétigny-sur-Orge
country: France
facility: Centre Ophtalmologique Brétigny Essonne
city: Corbeil Essonnes
country: France
facility: CH SUD Francilien Corbeil Essonne
city: Corbeil-Essonnes
country: France
facility: Centre d'examens de santé de la CPAM 93
city: Dijon
country: France
facility: Retinodiab Bourgogne
city: Montauban
country: France
facility: Clinique Honoré Cave
city: Nantes
country: France
facility: CHU Nantes
city: Roppe
country: France
facility: Retinodiab Franche-Comté
city: Toulouse
country: France
facility: Diabète Occitanie
city: Toulouse
country: France
facility: CHU Toulouse
city: Paris
country: France
facility: OPHDIAT
state: Île De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Aude Couturier, Dr
role: PRINCIPAL_INVESTIGATOR
References: