OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

Study Overview
=================
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.

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

Conditions
-----------------
Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy, Glaucoma

Intervention / Treatment
-----------------
* Device: Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diabetic patient group assessed for multiple eye diseases<br>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<br>* Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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