0.19毫克醋酸氟轻松植入物治疗玻璃体切割术后黄斑囊样水肿的疗效和安全性：ILUvien治疗术后黄斑囊样水肿研究
Efficacy and Safety of 0.19-mg Fluocinolone Acetonide Implant in Postoperative Cystoid Macular Edema after Pars Plana Vitrectomy: The ILUvien in Postoperative CYstoid Macular eDema Study.
作者信息
Motloch Karolina, Soler Vincent, Delyfer Marie-Noëlle, Vasseur Vivien, Wolff Benjamin, Issa Mohamad, Dot Corinne, Massé Hélène, Weber Michel, Comet Alban, Hitzl Wolfgang, Matonti Frederic, Creuzot-Garcher Catherine, Tadayoni Ramin, Kodjikian Laurent, Couturier Aude
机构信息
Department of Ophthalmology, Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, Germany; Lariboisière Hospital-Assistance Publique-Hôpitaux de Paris (AP-HP), Ophthalmology Department, Université Paris Cité, Paris, France.
Department of Ophthalmology, Hôpital Centre Hospitalier Universitaire (CHU) Purpan, Toulouse, France.
出版信息
Ophthalmol Retina. 2024 Dec;8(12):1181-1191. doi: 10.1016/j.oret.2024.07.004. Epub 2024 Jul 14.
PURPOSE
To assess the efficacy and safety of 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien) in treating chronic postoperative cystoid macular edema (PCME) after pars plana vitrectomy.
DESIGN
Retrospective multicentric case series in clinical settings.
SUBJECTS
Patients with chronic PCME who underwent vitrectomy in tertiary care centers in France.
METHODS
Review of charts and OCT scans.
MAIN OUTCOME MEASURES
The primary end points were the best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Secondary end points were the intraocular pressure (IOP); proportion of patients maintaining a BCVA ≥20/40; need for additional nonstudy treatment; differences between eyes that underwent a single and multiple surgeries; and OCT biomarkers of better BCVA.
RESULTS
Forty-nine eyes of 49 patients with a mean follow-up of 24.5 ± 3.87 months were included. The mean BCVA increased from 0.40 ± 0.26 logarithm of the minimum angle of resolution (logMAR) at baseline to 0.32 ± 0.24 logMAR at month 24 (P = 0.0035). The mean CRT decreased from 409 ± 139 μm at baseline to 340 ± 92 μm at month 24 (P = 0.0001). The mean IOP was 14.0 ± 4 mmHg at baseline and remained stable at 14.03 ± 4.1 mmHg at month 24 (P = 0.99). During the follow-up, the IOP exceeded 21 mmHg in 9 eyes, with one eye requiring cyclophotocoagulation. The BCVA was ≥20/40 in 47% of eyes (95% confidence interval [CI], 34%-61%) at baseline and in 58% of eyes at month 24 (95% CI, 41%-73%). At month 18, the likelihood of achieving a BCVA ≥20/40 was higher in eyes with intact external limiting membrane and ellipsoid zone. Additional dexamethasone (DEX) implant was injected in 14 eyes (28.6%). The treatment burden of 2.45 ± 1.35 DEX implant/y was decreased to 0.57 ± 0.60 DEX implant/y after FAc implantation (P = 0.001).
CONCLUSIONS
Fluocinolone acetonide implant improved the BCVA, reduced the CRT, and allowed reducing treatment burden in eyes with chronic PCME after vitrectomy. The safety profile was acceptable.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的
评估0.19毫克曲安奈德（FAc）玻璃体内植入物（Iluvien）治疗玻璃体切割术后慢性黄斑囊样水肿（PCME）的疗效和安全性。
设计
临床环境下的回顾性多中心病例系列研究。
研究对象
在法国三级医疗中心接受玻璃体切割术的慢性PCME患者。
方法
查阅病历和光学相干断层扫描（OCT）图像。
主要观察指标
主要终点为最佳矫正视力（BCVA）和中心视网膜厚度（CRT）。次要终点为眼压（IOP）；BCVA≥20/40的患者比例；是否需要额外的非研究性治疗；单眼手术和多眼手术患者之间的差异；以及与较好BCVA相关的OCT生物标志物。
结果
纳入49例患者的49只眼，平均随访24.5±3.87个月。平均BCVA从基线时的0.40±0.26最小分辨角对数（logMAR）提高到第24个月时的0.32±0.24 logMAR（P = 0.0035）。平均CRT从基线时的409±139μm降至第24个月时的340±92μm（P = 0.0001）。平均眼压在基线时为14.0±4 mmHg，在第24个月时保持稳定，为14.03±4.1 mmHg（P = 0.99）。随访期间，9只眼的眼压超过21 mmHg，其中1只眼需要进行睫状体光凝术。基线时47%的眼（95%置信区间[CI]，34%-61%）BCVA≥20/40，第24个月时为58%的眼（95% CI，41%-73%）。在第18个月时，外部限制膜和椭圆体带完整的眼中达到BCVA≥20/40的可能性更高。14只眼（28.6%）注射了额外的地塞米松（DEX）植入物。FAc植入后，DEX植入物的治疗负担从每年2.45±1.35次降至每年0.57±0.60次（P = 0.001）。
结论
曲安奈德植入物改善了BCVA，降低了CRT，并减轻了玻璃体切割术后慢性PCME患者的治疗负担。安全性可接受。
财务披露
在本文末尾的脚注和披露中可能会找到专有或商业披露信息。
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