Evidence map›Paper›PMID 40340790›Full record

ArticleBMJ open ophthalmology2025

Validation of artificial intelligence algorithm LuxIA for screening of diabetic retinopathy from a single 45° retinal colour fundus images: the CARDS study.

Rodrigo Abreu-Gonzalez, Gabriela Susanna-González, Joseph P M Blair, Romina M Lasagni Vitar, Carlos Ciller, Stefanos Apostolopoulos, Sandro De Zanet, José Natán Rodríguez Martín, Carlos Bermúdez, Alfonso Luis Calle Pascual and 5 more

Abstract readMulticenter StudyValidation Study
In one paragraph

Article in BMJ open ophthalmology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

15 authors.

Rodrigo Abreu-GonzalezOphthalmology, University Hospital of La Candelaria, La Matanza, Spain rodrigoabreug@gmail.com.ORCID 0000-0002-0354-4252
Gabriela Susanna-GonzálezOphthalmology Medical Affairs, Novartis Farmacéutica SA, Barcelona, Spain.ORCID 0009-0009-3137-3452
Joseph P M BlairRetinAI Medical AG, Bern, Switzerland.ORCID 0000-0003-3248-7039
Romina M Lasagni VitarRetinAI Medical AG, Bern, Switzerland.ORCID 0000-0003-1471-1682
Carlos CillerResearch, RetinAI Medical AG, Bern, Switzerland.ORCID 0009-0006-6450-5579
Stefanos ApostolopoulosRetinAI Medical AG, Bern, Switzerland.
Sandro De ZanetRetinAI Medical AG, Bern, Switzerland.ORCID 0000-0001-8983-4295
José Natán Rodríguez MartínIT Service, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain.
Carlos BermúdezInnovation & Digital Health Service, Servicio Canario de Salud, Santa Cruz de Tenerife, Spain.
Alfonso Luis Calle PascualEndocrinology & Nutrition Department, HCSC, Complutense University of Madrid, Madrid, Spain.
Elena RigoOphthalmology, Son Llàtzer Hospital, Palma de Mallorca, Spain.
Enrique Cervera TauletOphthalmology, CHGUV, Valencia, Spain.
Jose Juan Escobar-BarrancoOphthalmology, Hospital Dos de Maig, Barcelona, Spain.
Rosario Cobo-SorianoOphthalmology, Hospital Universitario del Henares, Coslada, Spain.
Juan Donate-LopezFundación VerSalud, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study validated the artificial intelligence (AI)-based algorithm LuxIA for screening more-than-mild diabetic retinopathy (mtmDR) from a single 45° colour fundus image of patients with diabetes mellitus (DM, type 1 or type 2) in Spain. Secondary objectives included validating LuxIA according to the International Clinical Diabetic Retinopathy (ICDR) classification and comparing its performance between different devices.

methodsIn this multicentre, cross-sectional study, retinal colour fundus images of adults (≥18 years) with DM were collected from five hospitals in Spain (December 2021-December 2022). 45° colour fundus photographs were captured using non-mydriatic Topcon and ZEISS cameras. The Discovery platform (RetinAI) was used to collect images. LuxIA output was an ordinal score (1-5), indicating a classification as mtmDR based on an ICDR severity score.

results945 patients with DM were included; the mean (SD) age was 64.6 (13.5) years. The LuxIA algorithm detected mtmDR with a sensitivity and specificity of 97.1% and 94.8%, respectively. The area under the receiver-operating characteristic curve was 0.96, indicating a high test accuracy. The 95% CI data for overall accuracy (94.8% to 95.6%), sensitivity (96.8% to 98.2%) and specificity (94.3% to 95.1%) indicated robust estimations by LuxIA, which maintained a concordance of classification (N=829, kappa=0.837, p=0.001) when used to classify Topcon images. LuxIA validation on ZEISS-obtained images demonstrated high accuracy (90.6%), specificity (92.3%) and lower sensitivity (83.3%) as compared with Topcon-obtained images.

conclusionsAI algorithms such as LuxIA are increasing testing feasibility for healthcare professionals in DR screening. This study validates the real-world utility of LuxIA for mtmDR screening.

Indexed as

AlgorithmsArtificial IntelligenceDiabetic RetinopathyMass ScreeningAdultAgedCross-Sectional StudiesFemaleFundus OculiHumansMaleMiddle AgedReproducibility of ResultsROC CurveSensitivity and SpecificitySpainDiagnostic tests/InvestigationImagingVision

Identifiers

PMID40340790
PMCPMC12067837

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