To assess real-world outcomes of fluocinolone acetonide (FAc) implant in treating diabetic macular edema (DME), a systematic literature review was conducted on PubMed in order to identify publications assessing the efficacy and safety of the FAc implant in DME in daily practice. Case reports and randomized controlled trials were excluded. Twenty-two observational real-world studies analyzing a total of 1880 eyes were included. Mean peak visual gain was +8.7 letters (11.3 months post-FAc injection) and was greater for lower baseline best corrected visual acuity (BCVA) and for more recent DME. Mean central retinal thickness (CRT) decreased 34.3% from baseline. 77.0% of the analyzed studies reported both BCVA improvement of at least five letters and a CRT decrease by 20% or more. Rescue therapy was needed more frequently when FAc was administered for chronic DME. FAc-induced ocular hypertension was reported in 20.1% of patients but only 0.6% needed surgery. Cataract extraction was performed in 43.2% of phakic patients. Adequate patient selection is essential for optimal FAc response and better safety profile. Currently positioned as second- or third-line treatment in the management algorithm, FAc implant decreases treatment burden and provides better letter gain when administered for more recent DME.

中文翻译：

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氟喹诺酮丙酮酸盐植入物治疗糖尿病性黄斑水肿的真实疗效和安全性：系统评价

为了评估氟轻松龙胆素（FAc）植入物治疗糖尿病性黄斑水肿（DME）的真实结果，在PubMed上进行了系统的文献综述，以鉴定评估FAc植入物在DME中的日常使用效果和安全性的出版物。病例报告和随机对照试验均不包括在内。包括22项观察性现实世界研究，总共分析了1880只眼睛。平均峰值视觉增益为+8.7个字母（FAc注射后11.3个月），并且对于较低的基线最佳矫正视力（BCVA）和最新的DME而言，平均峰值更高。平均中央视网膜厚度（CRT）比基线下降34.3％。77.0％的分析研究报告BCVA至少提高了5个字母，CRT降低了20％或更多。当对慢性DME施用FAc时，更需要急救治疗。据报道，FAc引起的高眼压症患者占20.1％，但只有0.6％的患者需要手术治疗。白内障摘除术在有晶状体眼的患者中占43.2％。充分的患者选择对于最佳FAc反应和更好的安全性至关重要。目前，FAc植入物在管理算法中定位为二线或三线治疗，当用于较新的DME时，可减轻治疗负担并提供更好的字母增益。