■要报告长期功能,对于持续性或复发性糖尿病性黄斑水肿(DME)患者,0.2μg/d氟轻松0.19mg的解剖学和安全性结果。
■回顾性,观察,复发性或持续性DME患者的单中心研究。所有患者接受0.2μg/天的氟轻松0.19mg,和数据收集在基线和植入后1,3,6,12,24和36个月.测量的结果包括最佳矫正视力(BCVA),黄斑中心厚度(CMT),眼内压(IOP),和安全结果。
■共纳入28例患者的28只眼。平均年龄为66.5岁(95%CI62.8-70.2),DME的平均持续时间为8.8年(95%CI7.7-10.0)。只有两只眼睛是phakic。平均随访时间为25.4个月(95%CI21.2-29.6)。基线时平均BCVA为48.6个ETDRS字母(95%CI41.3-55.8),早在随访1个月时就有所改善,平均BCVA增加7.8个ETDRS字母(95%CI4.3-11.3)(p<0.001)。在第6、12和24个月也观察到BCVA的统计学显著改善。在基线,患者的平均CMT为530.5µm(95%CI463.0-598.0),观察到CMT的减少,从随访的第一个月开始(平均CMT降低-170.5µm,95%CI-223.8--117.1;p<0.001)。在第6、12、24和36个月也观察到CMT的统计学显着下降,在第12个月观察到最大下降(p<0.001)。基线时的平均IOP为16.4mmHg(95%CI15.3-17.5),随访期间有9只眼睛(32.1%)的IOP≥21mmHg。
■我们的结果支持氟轻松的有效性和安全性。虽然需要额外的长期现实证据,氟轻松可能是一种安全的日常策略,低剂量,持续和局部释放到眼睛的后段,在DME中提供功能和解剖学益处。
UNASSIGNED: To report the long-term functional, anatomical and safety outcomes of 0.2 μg/day fluocinolone acetonide 0.19mg in patients with persistent or recurrent diabetic macular edema (DME).
UNASSIGNED: Retrospective, observational, single-center study of patients with recurrent or persistent DME. All patients received 0.2 μg/day of fluocinolone acetonide 0.19mg, and data were collected at baseline and months 1, 3, 6, 12, 24 and 36 after implantation. Outcomes measured included best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and safety outcomes.
UNASSIGNED: A total of 28 eyes from 28 patients were included. The mean age was 66.5 years (95% CI 62.8-70.2) with a mean duration of DME of 8.8 years (95% CI 7.7-10.0). Only two eyes were phakic. Mean follow-up was 25.4 months (95% CI 21.2-29.6). Mean BCVA at baseline was 48.6 ETDRS letters (95% CI 41.3-55.8) and improved as early as month 1 of follow-up with a mean gain in BCVA of 7.8 (95% CI 4.3-11.3) ETDRS letters (p<0.001). Statistically significant improvements in BCVA were also observed at months 6, 12 and 24. At baseline, patients had a mean CMT of 530.5µm (95% CI 463.0-598.0), and a decrease in CMT was observed, starting at the first month of follow-up (mean CMT reduction of -170.5µm, 95% CI -223.8- -117.1; p<0.001). Statistically significant decreases in CMT were also observed at months 6, 12, 24, and 36, with the maximum decrease observed at month 12 (p<0.001). Mean IOP at baseline was 16.4mmHg (95% CI 15.3-17.5) and nine eyes (32.1%) had an IOP ≥21mmHg during follow-up.
UNASSIGNED: Our results support the effectiveness and safety profile of fluocinolone acetonide. Although additional long-term real-world evidence is required, fluocinolone acetonide may represent a safe strategy for daily, low-dose, sustained and localized release to the posterior segment of the eye, providing both functional and anatomical benefits in DME.