OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
- Conditions
- Age-related MaculopathyDiabetic RetinopathyAge-Related Macular DegenerationDiabetic Macular EdemaGlaucoma
- Interventions
- Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
- Registration Number
- NCT05752045
- Lead Sponsor
- Evolucare Technologies
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1389
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.
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diabetic patient group assessed for multiple eye diseases Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed
- Primary Outcome Measures
Name Time Method Referable Diabetic Retinopathy screening sensitivity/specificity 1 year Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms
- Secondary Outcome Measures
Name Time Method Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection 1 year Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full , RD grading and DME algorithms combination
Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection 1 year Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full and RD grading algorithms combination
Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection 1 year Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha, RD grading and DME algorithms combination
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection 1 year Diabetic Macular Edema screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for DME algorithm
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion 1 year Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms
Diabetic retinopathy grading sensitivity/specificity 1 year Diabetic retinopathy grading performance (OphtAI software vs Expert reader) for each grading sub algorithms (sensitivity/specificity) and globally (accuracy/agreement ratio)
Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection 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
Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection 1 year Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RD grading algorithms combination
Quality algorithm accuracy for quality assessment 1 year Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms
Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection 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
Laterality determination algorithm accuracy for laterality assessment 1 year Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm
Trial Locations
- Locations (12)
Clinique Honoré Cave
🇫🇷Montauban, France
OPHDIAT
🇫🇷Paris, Île De France, France
CHU Brest
🇫🇷Brest, France
Centre Aix Vision
🇫🇷Aix-en-Provence, France
Centre d'examens de santé de la CPAM 93
🇫🇷Corbeil-Essonnes, France
Centre Ophtalmologique Brétigny Essonne
🇫🇷Brétigny-sur-Orge, France
CH SUD Francilien Corbeil Essonne
🇫🇷Corbeil Essonnes, France
Retinodiab Bourgogne
🇫🇷Dijon, France
CHU Nantes
🇫🇷Nantes, France
Retinodiab Franche-Comté
🇫🇷Roppe, France
Diabète Occitanie
🇫🇷Toulouse, France
CHU Toulouse
🇫🇷Toulouse, France