ImportanceOne of the biggest challenges when using anti–vascular endothelial growth factor (VEGF) agents to treat retinopathy of prematurity (ROP) is the need to perform long-term follow-up examinations to identify eyes at risk of ROP reactivation requiring retreatment.ObjectiveTo evaluate whether an artificial intelligence (AI)–based vascular severity score (VSS) can be used to analyze ROP regression and reactivation after anti-VEGF treatment and potentially identify eyes at risk of ROP reactivation requiring retreatment.Design, Setting, and ParticipantsThis prognostic study was a secondary analysis of posterior pole fundus images collected during the multicenter, double-blind, investigator-initiated Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP) randomized clinical trial, which compared 2 different doses of ranibizumab (0.12 mg vs 0.20 mg) for the treatment of ROP. The CARE-ROP trial screened and enrolled infants between September 5, 2014, and July 14, 2016. A total of 1046 wide-angle fundus images obtained from 19 infants at predefined study time points were analyzed. The analyses of VSS were performed between January 20, 2021, and November 18, 2022.InterventionsAn AI-based algorithm assigned a VSS between 1 (normal) and 9 (most severe) to fundus images.Main Outcomes and MeasuresAnalysis of VSS in infants with ROP over time and VSS comparisons between the 2 treatment groups (0.12 mg vs 0.20 mg of ranibizumab) and between infants who did and did not receive retreatment for ROP reactivation.ResultsAmong 19 infants with ROP in the CARE-ROP randomized clinical trial, the median (range) postmenstrual age at first treatment was 36.4 (34.7-39.7) weeks; 10 infants (52.6%) were male, and 18 (94.7%) were White. The mean (SD) VSS was 6.7 (1.9) at baseline and significantly decreased to 2.7 (1.9) at week 1 (P < .001) and 2.9 (1.3) at week 4 (P < .001). The mean (SD) VSS of infants with ROP reactivation requiring retreatment was 6.5 (1.9) at the time of retreatment, which was significantly higher than the VSS at week 4 (P < .001). No significant difference was found in VSS between the 2 treatment groups, but the change in VSS between baseline and week 1 was higher for infants who later required retreatment (mean [SD], 7.8 [1.3] at baseline vs 1.7 [0.7] at week 1) vs infants who did not (mean [SD], 6.4 [1.9] at baseline vs 3.0 [2.0] at week 1). In eyes requiring retreatment, higher baseline VSS was correlated with earlier time of retreatment (Pearson r = −0.9997; P < .001).Conclusions and RelevanceIn this study, VSS decreased after ranibizumab treatment, consistent with clinical disease regression. In cases of ROP reactivation requiring retreatment, VSS increased again to values comparable with baseline values. In addition, a greater change in VSS during the first week after initial treatment was found to be associated with a higher risk of later ROP reactivation, and high baseline VSS was correlated with earlier retreatment. These findings may have implications for monitoring ROP regression and reactivation after anti-VEGF treatment.
Zusammenfassung Hintergrund Seit 2018 ist mit IDx-DR ein Verfahren auf dem Markt, welches den Grad der diabetischen Retinopathie (DR) mittels künstlicher Intelligenz (KI) bestimmt. Methoden Wir haben IDx-DR in die Sprechstunde an einer diabetologischen Schwerpunktklinik integriert und berichten über die Übereinstimmung zwischen IDx-DR (IDx Technologies Inc., Coralville, IA, USA) und Funduskopie sowie IDx-DR und ophthalmologischer Bildbeurteilung sowie über den Einfluss unterschiedlicher Kamerasysteme. Ergebnisse Mit der Topcon-Kamera (n = 456; NW400, Topcon Medical Systems, Oakland, NJ, USA) konnte im Vergleich zur Zeiss-Kamera (n = 47; Zeiss VISUCAM 500, Carl Zeiss Meditec AG, Jena, Deutschland) häufiger eine ausreichende Bildqualität in Miosis erreicht werden. Insgesamt war bei etwa 60 % der Patienten eine IDx-DR-Analyse in Miosis möglich. Alle Patienten, bei denen keine IDx-DR-Analyse in Miosis möglich war, konnten in Mydriasis funduskopiert werden. Innerhalb der Gruppe der auswertbaren Befunde zeigte sich eine Übereinstimmung zwischen IDx-DR und augenärztlicher Funduoskopie in ca. 55 %, ein Überschätzen des Schweregrads durch IDx-DR in ca. 40 % und ein Unterschätzen in ca. 4 %. Die Sensitivität (Spezifität) für das Erkennen einer schweren, behandlungsbedürftigen Retinopathie lag bei 95,7 % (89,1 %) für Fälle mit auswertbaren Fundusaufnahmen und bei 65,2 % (66,7 %), wenn alle Fälle betrachtet werden (inklusive derjeniger ohne verwertbare Aufnahme in Miosis). Der Kappa-Koeffizient zeigt mit 0,334 (p < 0,001) eine ausreichende Übereinstimmung zwischen IDx-DR und ärztlicher Bildauswertung anhand des Fundusfotos unter Berücksichtigung aller Patienten mit auswertbarer IDx-DR-Analyse. Der Vergleich zwischen IDx-DR mit der ärztlichen Funduskopie ergibt unter denselben Voraussetzungen eine geringe Übereinstimmung mit einem Kappa-Wert von 0,168 (p < 0,001). Schlussfolgerung Die vorliegende Studie zeigt Möglichkeiten und Grenzen des KI-gestützten DR-Screenings auf. Eine wesentliche Einschränkung liegt in der Tatsache, dass bei ca. 40 % der Patienten keine ausreichenden Aufnahmen in Miosis gewonnen werden konnten. Wenn ausreichende Aufnahmen vorlagen, stimmten IDx-DR und augenärztliche Diagnose in über 50 % der Fälle überein. Ein Unterschätzen des Schweregrades durch IDx-DR kam selten vor. Für die Integration in augenärztlich unterstützten Sprechstunden erscheint uns das System grundsätzlich geeignet. Die hohe Rate an fehlenden Aufnahmen in Miosis stellt allerdings eine Limitation dar, die einen Einsatz ohne augenärztliche Kontrollmöglichkeit schwierig erscheinen lässt.
Macular edema (ME) is the most frequent vision threatening consequence after retinal vein occlusion (RVO). In this study, we evaluate the effect of dexamethasone intravitreal implants (DII, Ozurdex) in a real-life cohort of 99 patients with ME due to RVO. All patients who received DII for ME following RVO between 2011 and 2016 at the University Eye Hospital Freiburg, Germany and who had fully accessible electronic medical records were eligible for this study. Most of the patients included in this study were not treatment-naïve: 61 eyes had received prior anti-VEGF drugs, 6 eyes had received intravitreal corticosteroids (triamcinolone) and 15 had been treated with both; 17 eyes were treatment-naïve. Mean follow-up was 312 ± 310 days. Mean visual acuity (VA) was maintained throughout the observation period (mean VA at baseline: 66.7 ± 23.5 letters; at last observation 64.9 ± 28.3). Central retinal thickness (CRT) decreased from 526 ± 179 µm at baseline to 431 ± 199 µm. Mean intraocular pressure (IOP) increased from 14.4 ± 3.1 mmHg at baseline to 17.1 ± 6.3 mmHg. Cataract surgery was performed in 22% of phakic eyes. DII was used as second-line treatment in the majority of cases in this cohort. The fact that mean VA remained unchanged while mean CRT decreased illustrates that morphologic improvement does not always translate into functional gain. Mean IOP was maintained within normal limits and cataract formation was as expected in this age group.
Retinopathy of prematurity, short ROP, is still one of the leading causes of childhood blindness worldwide. The management of ROP, however, has changed tremendously during the last years. This article summarizes known risk factors for ROP, preventive measures and the updated version of the German recommendations for ROP-screening and treatment. A special focus is laid on new treatment options, in particular anti-VEGF treatment, as well as the post-operative and long-term follow-up after treatment. This article also emphasizes the need for joint data collection on an international level and presents the newly-developed initiative for a European wide data collection (EU-ROP) which will be introduced in 2021. All physicians treating ROP infants are welcome to join the EU-ROP initiative.
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