{"type":"trials","record":{"id":42092,"source_id":"clinicaltrials-gov","external_id":"NCT05752045","title":"OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases","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.","overall_status":"Unknown","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Evolucare Technologies","enrollment":1389,"countries":["France"],"start_date":"2023-06-28","completion_date":"2024-03-01","last_update_date":"2023-09-28","source_url":"https://clinicaltrials.gov/study/NCT05752045","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Unknown. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"OPHTAI-EVAL","age_range":"18 Years","comparator":null,"organization":"Evolucare Technologies","interventions":["Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Referable Diabetic Retinopathy screening sensitivity/specificity — 1 year","Diabetic retinopathy grading sensitivity/specificity — 1 year","Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection — 1 year","Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection — 1 ye…","Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection — 1 ye…","Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection —…","Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection — 1 year","Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection — 1 year","Age-Related Maculopathy algorithm (\"drusen\") sensitivity/specificity for ARM detection — 1 year","Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion — 1 year","Quality algorithm accuracy for quality assessment — 1 year","Laterality determination algorithm accuracy for laterality assessment — 1 year"],"design_description":"NA · SINGLE GROUP · SCREENING · NONE","source_has_results":false},"controlled_terms":["Diabetic Retinopathy","Diabetic Macular Edema","Age-Related Macular Degeneration","Age-related Maculopathy","Glaucoma","Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct05752045","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2023-06-28 to 2024-03-01","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.919Z","intervention":["Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device"],"participants":1389,"study_design":"NA · SINGLE GROUP · SCREENING · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Referable Diabetic Retinopathy screening sensitivity/specificity — 1 year","Diabetic retinopathy grading sensitivity/specificity — 1 year","Diabetic retinopathy grading + RDR-EOphtha algorithms combination sensitivity/specificity for RDR detection — 1 year","Diabetic retinopathy grading + RDR-OphDiaT_full algorithms combination sensitivity/specificity for RDR detection — 1 ye…","Diabetic retinopathy grading + RDR-EOphtha +DME algorithms combination sensitivity/specificity for RDR detection — 1 ye…","Diabetic retinopathy grading + RDR-OphDiaT_full +DME algorithms combination sensitivity/specificity for RDR detection —…","Diabetic Macular Edema algorithm sensitivity/specificityfor DME detection — 1 year","Age-Related Macular Degeneration algorithm sensitivity/specificity for AMD detection — 1 year","Age-Related Maculopathy algorithm (\"drusen\") sensitivity/specificity for ARM detection — 1 year","Glaucoma algorithms sensitivity/specificity for Glaucoma suspicion — 1 year","Quality algorithm accuracy for quality assessment — 1 year","Laterality determination algorithm accuracy for laterality assessment — 1 year"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/42092","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}