Pivotal Evaluation of an Artificial Intelligence System for Autonomous Detection of Referrable and Vision-Threatening Diabetic Retinopathy.

Autor:	Ipp E; The Lundquist Institute, Harbor-UCLA Medical Center, Torrance, California., Liljenquist D; Rocky Mountain Diabetes Center, Idaho Falls, Idaho., Bode B; Atlanta Diabetes Associates, Atlanta, Georgia., Shah VN; Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado., Silverstein S; Silverstein Eye Centers, Kansas City, Missouri., Regillo CD; Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania., Lim JI; Department of Ophthalmology, Illinois Eye and Ear Infirmary, University of Illinois University of Illinois at Chicago, Chicago, Illinois., Sadda S; Doheny Eye Center, Arcadia, California., Domalpally A; Fundus Photograph Reading Center, University of Wisconsin-Madison, Madison, Wisconsin., Gray G; Data-Fi, LLC, Silver Spring, Maryland., Bhaskaranand M; Eyenuk Inc, Los Angeles, California., Ramachandra C; Eyenuk Inc, Los Angeles, California., Solanki K; Eyenuk Inc, Los Angeles, California.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2021 Nov 01; Vol. 4 (11), pp. e2134254. Date of Electronic Publication: 2021 Nov 01.
DOI:	10.1001/jamanetworkopen.2021.34254
Abstrakt:	Importance: Diabetic retinopathy (DR) is a leading cause of blindness in adults worldwide. Early detection and intervention can prevent blindness; however, many patients do not receive their recommended annual diabetic eye examinations, primarily owing to limited access. Objective: To evaluate the safety and accuracy of an artificial intelligence (AI) system (the EyeArt Automated DR Detection System, version 2.1.0) in detecting both more-than-mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR). Design, Setting, and Participants: A prospective multicenter cross-sectional diagnostic study was preregistered (NCT03112005) and conducted from April 17, 2017, to May 30, 2018. A total of 942 individuals aged 18 years or older who had diabetes gave consent to participate at 15 primary care and eye care facilities. Data analysis was performed from February 14 to July 10, 2019. Interventions: Retinal imaging for the autonomous AI system and Early Treatment Diabetic Retinopathy Study (ETDRS) reference standard determination. Main Outcomes and Measures: Primary outcome measures included the sensitivity and specificity of the AI system in identifying participants' eyes with mtmDR and/or vtDR by 2-field undilated fundus photography vs a rigorous clinical reference standard comprising reading center grading of 4 wide-field dilated images using the ETDRS severity scale. Secondary outcome measures included the evaluation of imageability, dilated-if-needed analysis, enrichment correction analysis, worst-case imputation, and safety outcomes. Results: Of 942 consenting individuals, 893 patients (1786 eyes) met the inclusion criteria and completed the study protocol. The population included 449 men (50.3%). Mean (SD) participant age was 53.9 (15.2) years (median, 56; range, 18-88 years), 655 were White (73.3%), and 206 had type 1 diabetes (23.1%). Sensitivity and specificity of the AI system were high in detecting mtmDR (sensitivity: 95.5%; 95% CI, 92.4%-98.5% and specificity: 85.0%; 95% CI, 82.6%-87.4%) and vtDR (sensitivity: 95.1%; 95% CI, 90.1%-100% and specificity: 89.0%; 95% CI, 87.0%-91.1%) without dilation. Imageability was high without dilation, with the AI system able to grade 87.4% (95% CI, 85.2%-89.6%) of the eyes with reading center grades. When eyes with ungradable results were dilated per the protocol, the imageability improved to 97.4% (95% CI, 96.4%-98.5%), with the sensitivity and specificity being similar. After correcting for enrichment, the mtmDR specificity increased to 87.8% (95% CI, 86.3%-89.5%) and the sensitivity remained similar; for vtDR, both sensitivity (97.0%; 95% CI, 91.2%-100%) and specificity (90.1%; 95% CI, 89.4%-91.5%) improved. Conclusions and Relevance: This prospective multicenter cross-sectional diagnostic study noted safety and accuracy with use of the EyeArt Automated DR Detection System in detecting both mtmDR and, for the first time, vtDR, without physician assistance. These findings suggest that improved access to accurate, reliable diabetic eye examinations may increase adherence to recommended annual screenings and allow for accelerated referral of patients identified as having vtDR.
Databáze:	MEDLINE
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