0.19毫克醋酸氟西诺龙植入剂治疗玻璃体旁切除术后囊样黄斑水肿的有效性和安全性:ILUCYD研究。

IF 4.4 Q1 OPHTHALMOLOGY Ophthalmology. Retina Pub Date : 2024-12-01 Epub Date: 2024-07-14 DOI:10.1016/j.oret.2024.07.004
Karolina Motloch, Vincent Soler, Marie-Noëlle Delyfer, Vivien Vasseur, Benjamin Wolff, Mohamad Issa, Corinne Dot, Hélène Massé, Michel Weber, Alban Comet, Wolfgang Hitzl, Frederic Matonti, Catherine Creuzot-Garcher, Ramin Tadayoni, Laurent Kodjikian, Aude Couturier
{"title":"0.19毫克醋酸氟西诺龙植入剂治疗玻璃体旁切除术后囊样黄斑水肿的有效性和安全性:ILUCYD研究。","authors":"Karolina Motloch, Vincent Soler, Marie-Noëlle Delyfer, Vivien Vasseur, Benjamin Wolff, Mohamad Issa, Corinne Dot, Hélène Massé, Michel Weber, Alban Comet, Wolfgang Hitzl, Frederic Matonti, Catherine Creuzot-Garcher, Ramin Tadayoni, Laurent Kodjikian, Aude Couturier","doi":"10.1016/j.oret.2024.07.004","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Design: </strong>Retrospective multicentric case series in clinical settings.</p><p><strong>Subjects: </strong>Patients with chronic PCME who underwent vitrectomy in tertiary care centers in France.</p><p><strong>Methods: </strong>Review of charts and OCT scans.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":"1181-1191"},"PeriodicalIF":4.4000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Karolina Motloch, Vincent Soler, Marie-Noëlle Delyfer, Vivien Vasseur, Benjamin Wolff, Mohamad Issa, Corinne Dot, Hélène Massé, Michel Weber, Alban Comet, Wolfgang Hitzl, Frederic Matonti, Catherine Creuzot-Garcher, Ramin Tadayoni, Laurent Kodjikian, Aude Couturier\",\"doi\":\"10.1016/j.oret.2024.07.004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Design: </strong>Retrospective multicentric case series in clinical settings.</p><p><strong>Subjects: </strong>Patients with chronic PCME who underwent vitrectomy in tertiary care centers in France.</p><p><strong>Methods: </strong>Review of charts and OCT scans.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>\",\"PeriodicalId\":19501,\"journal\":{\"name\":\"Ophthalmology. Retina\",\"volume\":\" \",\"pages\":\"1181-1191\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. Retina\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1016/j.oret.2024.07.004\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmology. Retina","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.oret.2024.07.004","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/14 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:评估0.19毫克氟西诺龙(FAc)玻璃体内植入剂(Iluvien®)治疗玻璃体旁切除术后慢性囊样黄斑水肿(PCME)的有效性和安全性:研究对象:接受玻璃体旁切除术的慢性 PCME 患者:研究对象:在法国三级医疗中心接受玻璃体切除术的慢性囊样黄斑水肿患者。所有眼球在植入FAc前均已证实对DEX植入反应良好:主要结果测量:主要终点是最佳矫正视力(BCVA)和视网膜中央厚度(CRT)。次要终点为眼压(IOP);维持BCVA≥20/40的患者比例;是否需要额外的非研究治疗;接受单次手术和多次手术的眼睛之间的差异以及改善BCVA的OCT生物标志物:共纳入49名患者的49只眼睛,平均随访时间为(24.5 ± 3.9)个月。平均BCVA从基线时的0.40 ± 0.26 logMAR增加到第24个月(M24)时的0.32 ± 0.24 logMAR(P=0.0035)。平均 CRT 从基线时的 409.37 ± 139.43 μm 下降到第 24 个月时的 340 ± 91 μm(p=0.0001)。基线时的平均眼压为 14.0 ± 4 mmHg,M24 时稳定在 14.03 ± 4.1 mmHg(p=0.99)。随访期间,9 只眼睛的眼压超过了 21 mmHg。除一只眼睛需要进行环形光凝外,其他眼睛的眼压上升均通过局部治疗得到控制。基线时,47% 的眼睛 BCVA 值≥20/40(95% CI:34%-61%),M24 时,58% 的眼睛 BCVA 值≥20/40(95% CI:41%-73%)。在 M18 时,外缘膜和椭圆体区完好的眼睛获得 BCVA ≥20/40 的可能性更高。有 14 只眼睛(28.57%)额外注射了地塞米松植入剂(DEXi)。FAc植入术后,治疗负担从2.45 ± 1.35 DEXi/年降至0.57 ± 0.60 DEXi/年(P=0.001):结论:FAc植入改善了玻璃体切割术后慢性PCME患者的BCVA,降低了CRT。结论:玻璃体切除术后,FAc 植入体改善了慢性 PCME 患者的 BCVA,降低了 CRT。在慢性 PCME 患者中植入 FAc 还能减轻治疗负担。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.

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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Ophthalmology. Retina
Ophthalmology. Retina Medicine-Ophthalmology
CiteScore
7.80
自引率
6.70%
发文量
274
审稿时长
33 days
期刊最新文献
A meta-analysis of intravitreal ranibizumab versus laser photocoagulation for the treatment of retinopathy of prematurity. Macular Atrophy in Neovascular Age-Related Macular Degeneration: A Systematic Review and Meta-Analysis. Persistence of Retinal Fluid after Anti-VEGF treatment for neovascular age-related macular degeneration: A Systematic Review and Meta-Analysis. Choroidal Nevus with Mega Druse. Re: Sánchez-Vela at al.: Reverse pupillary block after implantation of a sutureless scleral fixation Carlevale intraocular lens (Ophthalmology Retina. 2024 Oct 15:S2468-6530(24)00475-5. doi: 10.1016/j.oret.2024.10.004. Online ahead of print.).
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1