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OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases (OPHTAI-EVAL)

Primary Purpose

Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
Sponsored by
Evolucare Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Retinopathy focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Aix VisionRecruiting
  • CHU BrestRecruiting
  • Centre Ophtalmologique Brétigny EssonneRecruiting
  • CH SUD Francilien Corbeil EssonneRecruiting
  • Centre d'examens de santé de la CPAM 93Recruiting
  • Retinodiab BourgogneRecruiting
  • Clinique Honoré Cave
  • CHU Nantes
  • Retinodiab Franche-Comté
  • Diabète OccitanieRecruiting
  • CHU ToulouseRecruiting
  • OPHDIAT

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diabetic patient group assessed for multiple eye diseases

Arm Description

Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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
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
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
Diabetic Macular Edema screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for DME algorithm
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
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
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms
Quality algorithm accuracy for quality assessment
Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms
Laterality determination algorithm accuracy for laterality assessment
Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm

Full Information

First Posted
January 25, 2023
Last Updated
September 25, 2023
Sponsor
Evolucare Technologies
Collaborators
Slb Pharma, Assistance Publique - Hôpitaux de Paris, BPIfrance
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1. Study Identification

Unique Protocol Identification Number
NCT05752045
Brief Title
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evolucare Technologies
Collaborators
Slb Pharma, Assistance Publique - Hôpitaux de Paris, BPIfrance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
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.
Allocation
N/A
Enrollment
1389 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetic patient group assessed for multiple eye diseases
Arm Type
Other
Arm Description
Each patient eye disease status will be assessed by expert readers so to provide ground truth against which algorithms performances will be assessed
Intervention Type
Device
Intervention Name(s)
Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
Intervention Description
Double ophthalmological imaging capture of eye fundus with different fundus camera to screen patient for various eye diseases.
Primary Outcome Measure Information:
Title
Referable Diabetic Retinopathy screening sensitivity/specificity
Description
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Diabetic retinopathy grading sensitivity/specificity
Description
Diabetic retinopathy grading performance (OphtAI software vs Expert reader) for each grading sub algorithms (sensitivity/specificity) and globally (accuracy/agreement ratio)
Time Frame
1 year
Title
Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection
Description
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RD grading algorithms combination
Time Frame
1 year
Title
Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection
Description
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full and RD grading algorithms combination
Time Frame
1 year
Title
Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection
Description
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha, RD grading and DME algorithms combination
Time Frame
1 year
Title
Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection
Description
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-OphDiaT_full , RD grading and DME algorithms combination
Time Frame
1 year
Title
Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection
Description
Diabetic Macular Edema screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for DME algorithm
Time Frame
1 year
Title
Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection
Description
AMD screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for AMD algorithm, for all forms and for either atrophic or neovascular AMD
Time Frame
1 year
Title
Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection
Description
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
Time Frame
1 year
Title
Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion
Description
Glaucoma screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for Glaucoma algorithms
Time Frame
1 year
Title
Quality algorithm accuracy for quality assessment
Description
Bad quality images sensitivity/specificity evaluation (OphtAI software vs Expert reader) for quality assessment algorithms
Time Frame
1 year
Title
Laterality determination algorithm accuracy for laterality assessment
Description
Laterality accuracy of OphtAI software vs Expert reader for laterality determination algorithm
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ophélie Flageul
Phone
02 23 06 11 13
Ext
0033
Email
o.flageul@slbpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Borderie
Phone
0762879928
Ext
0033
Email
l.borderie@evolucare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aude Couturier, Dr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Aix Vision
City
Aix-en-Provence
ZIP/Postal Code
13090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien Guigou, Dr
Phone
0442992151
Email
s.guigou@wanadoo.fr
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Béatrice Cochener, Pr
Email
beatrice.cochener@ophtalmologie-chu29.fr
First Name & Middle Initial & Last Name & Degree
Tanguy Thierry, Dr
Email
tbahnguy@gmail.com
Facility Name
Centre Ophtalmologique Brétigny Essonne
City
Brétigny-sur-Orge
ZIP/Postal Code
91220
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte Dupas, Dr
Phone
0183639797
Email
dupas@coss.paris
Facility Name
CH SUD Francilien Corbeil Essonne
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Penfornis, Pr
Phone
0161697457
Email
alfred.penfornis@chsf.fr
Facility Name
Centre d'examens de santé de la CPAM 93
City
Corbeil-Essonnes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Laboulaye, Dr
Phone
0172595513
Email
philippe.laboulaye@assurance-maladie.fr
Facility Name
Retinodiab Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Creuzot-Garcher, Pr
Email
catherine.creuzot-garcher@chu-dijon.fr
Facility Name
Clinique Honoré Cave
City
Montauban
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Gualino, Dr
Email
vincent.gualino@gmail.com
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Retinodiab Franche-Comté
City
Roppe
ZIP/Postal Code
90380
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bobey, Dr
Email
Pierre_orianne@yahoo.fr
Facility Name
Diabète Occitanie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Christine Chauchard, Dr
Email
chauchard.mc@diabeteoccitanie.org
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Pagot-Mathis, Dr
Email
pagot-mathis.v@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Hélène Hanaire, Pr
Email
hanaire.h@chu-toulouse.fr
Facility Name
OPHDIAT
City
Paris
State/Province
Île De France
ZIP/Postal Code
75000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aude Couturier, Dr
Email
aude.couturier@aphp.fr
First Name & Middle Initial & Last Name & Degree
Ali Erginay, Dr
Email
ali.erginay@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases

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