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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
| Assistance Publique - Hôpitaux de Paris | OTHER |
| BPIfrance | OTHER |
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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.
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:
Evolucare OphtAI, is available on the French market since March 2019.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patient group assessed for multiple eye diseases | Other | Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device | Device | Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases. |
| Measure | Description | Time Frame |
|---|---|---|
| Referable Diabetic Retinopathy screening sensitivity/specificity | Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetic retinopathy grading sensitivity/specificity | 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 |
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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
Exclusion Criteria:
The following characteristics do not allow the subject to take part in the research:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ophélie Flageul | Contact | 02 23 06 11 13 | 0033 | o.flageul@slbpharma.com |
| Laurent Borderie | Contact | 0762879928 | 0033 | l.borderie@evolucare.com |
| Name | Affiliation | Role |
|---|---|---|
| Aude Couturier, Dr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Aix Vision | Recruiting | Aix-en-Provence | 13090 | France |
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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
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Ground truth and Results being obtained in the end of recruitment and imaging collection, there are no effects on participant or care provider. Also, experts won't be aware of AI results and vice versa.
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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 | 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 | 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 | 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 | 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 | 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 | 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 | Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms | 1 year |
| Quality algorithm accuracy for quality assessment | Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms | 1 year |
| Laterality determination algorithm accuracy for laterality assessment | Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm | 1 year |
| CHU Brest | Recruiting | Brest | France |
|
| Centre Ophtalmologique Brétigny Essonne | Recruiting | Brétigny-sur-Orge | 91220 | France |
|
| CH SUD Francilien Corbeil Essonne | Recruiting | Corbeil-Essonnes | 91100 | France |
|
| Centre d'examens de santé de la CPAM 93 | Recruiting | Corbeil-Essonnes | France |
|
| Retinodiab Bourgogne | Recruiting | Dijon | France |
|
| Clinique Honoré Cave | Not yet recruiting | Montauban | France |
|
| CHU Nantes | Active, not recruiting | Nantes | 44000 | France |
| Retinodiab Franche-Comté | Not yet recruiting | Roppe | 90380 | France |
|
| Diabète Occitanie | Recruiting | Toulouse | 31059 | France |
|
| CHU Toulouse | Recruiting | Toulouse | France |
|
| OPHDIAT | Not yet recruiting | Paris | Île-de-France Region | 75000 | France |
|
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008268 | Macular Degeneration |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D012162 | Retinal Degeneration |
| D009798 | Ocular Hypertension |
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