Faculty of Medicine, Benha University, Benha, Egypt.
Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates.
Eur J Ophthalmol. 2021 Nov;31(6):3196-3202. doi: 10.1177/1120672120982948. Epub 2021 Jan 10.
To evaluate 12-month outcomes following fluocinolone acetonide (FAc 0.2 μg/day) implant in pseudophakic patients with diabetic macular edema (DME) that persists or recurs despite previous treatment with anti-vascular endothelial growth factors (anti-VEGF) and dexamethasone implant (DEX) in a UAE population.
A retrospective, observational, single-center, 12-month audit study, where 22 pseudophakic eyes (22 patients) with DME were treated with the FAc intravitreal implant according to licensed UAE indications. Outcome measurements at baseline and at months 1, 3, 6, and 12 included best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP).
Post-FAc implantation, mean BCVA significantly improved at 1, 3, and 12 months (+10.4 ± 16.1, +22.8 ± 13.6, and +25.5 ± 13.0 letters, respectively; < 0.0001), with 86% of eyes gaining ⩾15 letters at month 12. Similarly, CMT reduced significantly at month 1, and stabilized thereafter at months 3-12 (-171.5 ± 72.5 µm, -240.9 ± 74.2 µm, and -246.2 ± 93.4 µm, respectively; < 0.0001). By month 12, 64% ( = 14/22) of eyes had a CMT below 300 µm. Only 1 eye had an IOP ⩾ 21 mmHg at baseline and month 12. Five eyes required IOP lowering drops and 1 required IOP-lowering surgical intervention.
In pseudophakic patients with DME FAc implant provide a substantial functional and anatomical benefits for up to 12 months.
评估在阿联酋人群中,对于先前接受抗血管内皮生长因子(anti-VEGF)和地塞米松植入物(DEX)治疗后仍持续或复发的糖尿病性黄斑水肿(DME)的白内障术后患者,氟轻松醋酸酯(FAc)0.2μg/天)植入物治疗 12 个月的结果。
回顾性、观察性、单中心、12 个月的审计研究,22 只白内障术后眼睛(22 名患者)患有 DME,根据阿联酋许可的适应症接受 FAc 玻璃体内植入物治疗。基线和 1、3、6 和 12 个月的疗效测量包括最佳矫正视力(BCVA)、中央黄斑厚度(CMT)和眼内压(IOP)。
FAc 植入后,1、3 和 12 个月时平均 BCVA 显著提高(分别为+10.4±16.1、+22.8±13.6 和+25.5±13.0 个字母;<0.0001),86%的眼睛在 12 个月时获得≥15 个字母。同样,CMT 在第 1 个月显著降低,此后在第 3-12 个月稳定(-171.5±72.5μm、-240.9±74.2μm 和-246.2±93.4μm,分别;<0.0001)。在 12 个月时,64%(22 只眼睛中有 14 只)的眼睛 CMT 低于 300μm。只有 1 只眼睛在基线和 12 个月时的 IOP ⩾21mmHg。5 只眼睛需要降低眼压的眼药水,1 只需要眼压降低的手术干预。
在白内障术后 DME 患者中,FAc 植入物在长达 12 个月的时间内提供了显著的功能和解剖学益处。