慢性中心性漿液性網脈絡膜症に対する低線量光線力学療法の有効性:傾向スコア解析

京都大学新制・課程博士博士(医学)甲第25159号医博第5045号京都大学大学院医学研究科医学専攻(主査)教授 中山 健夫, 教授 森田 智視, 教授 永井 洋士学位規則第4条第1項該当Doctor of Medical ScienceKyoto UniversityDFA

Effectiveness of Reduced-fluence Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

[Purpose] To investigate the 2-year effectiveness of reduced-fluence photodynamic therapy (rf-PDT) for chronic central serous chorioretinopathy (cCSC). [Design] Retrospective cohort study. [Participants] A total of 223 consecutive patients with newly diagnosed cCSC with active serous retinal detachment (SRD) were included from May 2007 to June 2017 and followed up for at least 2 years. Patients who underwent ocular treatment other than cataract surgery before the beginning of recruitment and those who had macular neovascularization at baseline were excluded. [Methods] All patients underwent a comprehensive ophthalmic evaluation, including measurements of best-corrected visual acuity (BCVA), slit-lamp examination, dilated fundus examination, color fundus photography, fundus autofluorescence, fluorescein angiography, indocyanine green angiography, and spectral-domain OCT. An inverse probability of treatment weighting (IPTW) methodology was applied to balance 18 baseline characteristics between patients who received rf-PDT (rf-PDT group) and those who did not receive treatment (controls). Inverse probability of treatment weighting survival analysis and regression were performed. [Main Outcome Measures] The proportion of patients whose BCVA at 24 months was the same or improved compared with the baseline visual acuity (VA) (VA maintenance rate). [Results] A total of 155 eyes (rf-PDT group: 74; controls: 81) were analyzed. The patients’ backgrounds were well balanced after IPTW with standardized differences of < 0.10. An IPTW regression analysis revealed that the VA maintenance rate was significantly higher in the rf-PDT group than in the controls (93.6% vs. 70.9%, P < 0.001, 12 months; 85.7% vs. 69.8%, P = 0.019, 24 months). The rf-PDT group tended to show better VA improvement, but was not statistically significant (–0.06 vs. –0.008, P = 0.07, 12 months; –0.06 vs. –0.03, P = 0.32, 24 months). An IPTW Cox regression showed a significantly higher rate of complete SRD remission in the rf-PDT group (hazard ratio, 5.05; 95% confidence interval, 3.24–7.89; P < 0.001). [Conclusions] The study suggests the beneficial effect of rf-PDT for cCSC for both VA maintenance and higher proportion of complete SRD remission in the clinical setting

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review

Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements. Author summary Artificial Intelligence (AI), Machine learning (ML)/deep learning (DL) is in the early stages of its applications in the medical field. The current study, by investigating the state of regulatory-approved ML/DL-based medical devices in Japan, revealed that the clinical application of AI-based medical devices is closely related to society. It also emphasizes the need to understand the industrial demand, and sociocultural situation of each country, such as the state of health insurance, medical access, and health awareness, for global expansion of ML/DL-based medical devices. The study consists one of the two studies that revealed the approval status of AI-related medical devices among the leading members of international regulatory harmonization. Revealing the regulatory status of each country provides a global overview that can foster international competitiveness and further tailored advancements of ML/DL-based medical devices. Considering the current lack of relevant information about such devices, further studies revealing the status of regulatory-approved ML/DL-based medical devices are expected

Regulatory-approved deep learning/machine learning-based medical devices in Japan as of 2020: A systematic review.

Machine learning (ML) and deep learning (DL) are changing the world and reshaping the medical field. Thus, we conducted a systematic review to determine the status of regulatory-approved ML/DL-based medical devices in Japan, a leading stakeholder in international regulatory harmonization. Information about the medical devices were obtained from the Japan Association for the Advancement of Medical Equipment search service. The usage of ML/DL methodology in the medical devices was confirmed using public announcements or by contacting the marketing authorization holders via e-mail when the public announcements were insufficient for confirmation. Among the 114,150 medical devices found, 11 were regulatory-approved ML/DL-based Software as a Medical Device, with 6 products (54.5%) related to radiology and 5 products (45.5%) related to gastroenterology. The domestic ML/DL-based Software as a Medical Device were mostly related to health check-ups, which are common in Japan. Our review can help understanding the global overview that can foster international competitiveness and further tailored advancements