Trials / Unknown
UnknownNCT05752045
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,389 (estimated)
- Sponsor
- Evolucare Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Diabetic Retinopathy
- Diabetic Macular Edema
- Age-Related Macular Degeneration
- Age-related Maculopathy
- Glaucoma
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-06-28
- Primary completion
- 2023-10-01
- Completion
- 2024-03-01
- First posted
- 2023-03-02
- Last updated
- 2023-09-28
Locations
12 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05752045. Inclusion in this directory is not an endorsement.