{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T16:10:46Z","timestamp":1792858246227,"version":"4.5.0"},"reference-count":38,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,7,21]]},"abstract":"\n Importance<\/jats:title>\n Screening for diabetic retinopathy using fundus photographs is the global standard of care but results in high false-positive referrals to evaluate diabetic macular edema (DME), placing a substantial burden on specialist eye clinics. Integrating an AI-based optical coherence tomography (AI-OCT) system into screening pathways may reduce potentially unnecessary referrals.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the diagnostic and referral performance of an AI-OCT system for DME detection within a diabetic retinopathy screening pathway in clinical settings.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Stepwise evaluation conducted in Hong Kong Special Administrative Region: a prospective silent-mode validation (February 2020 to July 2023) recruiting 603 patients with diabetes at a tertiary hospital triage unit, followed by a multicenter noninferiority RCT (September 2023 to April 2025), with follow-up completed in May 2025, recruiting 276 patients with suspected DME referred from a territory-wide diabetic retinopathy screening program.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n RCT participants were randomized to intervention (referral for DME evaluation based on both fundus photograph\u2013based screening reports and AI-OCT reports [n\u2009=\u2009137]) or control (automatic referral based solely on fundus photograph\u2013based screening reports [n\u2009=\u2009139]) groups. The AI-OCT system incorporated image-quality assessment, DME detection, and uncertainty flagging. Study outcomes focused on referral rates under the 2 pathways; for ethical reasons, all participants ultimately underwent specialist evaluation.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was false-positive DME referral rate, with a prespecified noninferiority margin of 20%. The secondary outcomes included sensitivity and specificity for DME detection and DME referral.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In prospective silent-mode validation (mean age, 64.7 [SD, 9.4] years; 56.2% male), 86 of 1200 scans (7.2%) were identified as ungradable and 49 of 1114 gradable scans (4.4%) were classified as uncertain. The system achieved 98.8% (95% CI, 94.5%-100.0%) sensitivity and 90.7% (95% CI, 88.7%-92.4%) specificity for DME detection. In the RCT (mean age, 63.9 [SD, 10.9] years; 54.7% male), DME prevalence was similar in the intervention and control groups (30.9% vs 29.9%). The false-positive DME referral rate was 24.1% (95% CI, 14.6%-37.0%) and 69.1% (95% CI, 61.0%-76.1%), respectively (absolute difference, \u221245% [95% CI, \u221258.2% to \u221231.9%;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001 for noninferiority]; upper bound of the CI below the prespecified noninferiority margin of 20%). Sensitivity for DME referral was 100.0% (95% CI, 100.0%-100.0%) in both groups. Specificity for DME referral was 86.5% (95% CI, 79.3%-92.9%) in the intervention group and 0.0% (95% CI, 0.0%-0.0%) in the control group. No cases of DME occurred among nonreferred participants in the intervention group.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Compared with standard practice, incorporation of the AI-OCT system as a secondary screening tool was noninferior with respect to false-positive referral rates and was associated with a substantial reduction in potentially unnecessary DME referrals without compromising sensitivity.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n Chinese Clinical Trial Registry:\n ChiCTR2300075087<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2026.7025","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T15:30:24Z","timestamp":1781537424000},"page":"215","source":"Crossref","is-referenced-by-count":1,"title":["An AI-Based OCT System to Detect Diabetic Macular Edema"],"prefix":"10.1001","volume":"336","author":[{"given":"Shuyi","family":"Zhang","sequence":"first","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anran","family":"Ran","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiaying","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anni","family":"Ling","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaiser","family":"Sham","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ziqi","family":"Tang","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Truong X.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawei","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naiman","family":"Lam","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Special Administrative Region (SAR), China"},{"name":"Hong Kong Eye Hospital, Hong Kong SAR, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hunter K. 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