Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,389
- 试验地点
- 19
- 主要终点
- Referable Diabetic Retinopathy screening sensitivity/specificity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Referable Diabetic Retinopathy screening sensitivity/specificity
时间窗: 1 year
Referable Diabetic Retinopathy screening sensitivity/specificity evaluation (OphtAI software vs Expert reader) for RDR-EOphtha and RDR-OphDiaT_full algorithms
次要结局
- Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection(1 year)
- Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection(1 year)
- Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection(1 year)
- Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection(1 year)
- Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion(1 year)
- Diabetic retinopathy grading sensitivity/specificity(1 year)
- Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection(1 year)
- Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection(1 year)
- Quality algorithm accuracy for quality assessment(1 year)
- Age-Related Maculopathy algorithm ("drusen") sensitivity/specificity for ARM detection(1 year)
- Laterality determination algorithm accuracy for laterality assessment(1 year)