OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

Glaucoma Clinical Trial

— OPHTAI-EVAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752045
• Other study ID #: 2022-A01813-40
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: Evolucare Technologies
• Contact: Ophélie Flageul
• Phone: 02 23 06 11 13
• Email: o.flageul[@]slbpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1389
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Age-related Maculopathy
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Glaucoma
• Macular Degeneration
• Macular Edema
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Centre Aix Vision	Aix-en-Provence
France	CHU Brest	Brest
France	Centre Ophtalmologique Brétigny Essonne	Brétigny-sur-Orge
France	CH SUD Francilien Corbeil Essonne	Corbeil Essonnes
France	Centre d'examens de santé de la CPAM 93	Corbeil-Essonnes
France	Retinodiab Bourgogne	Dijon
France	Clinique Honoré Cave	Montauban
France	CHU Nantes	Nantes
France	OPHDIAT	Paris	Île De France
France	Retinodiab Franche-Comté	Roppe
France	CHU Toulouse	Toulouse
France	Diabète Occitanie	Toulouse

Sponsors (4)

Lead Sponsor	Collaborator
Evolucare Technologies	Assistance Publique - Hôpitaux de Paris, BPIfrance, Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion	Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms	1 year
Secondary	Quality algorithm accuracy for quality assessment	Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms	1 year
Secondary	Laterality determination algorithm accuracy for laterality assessment	Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm	1 year