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Complications of intravitreal ocriplasmin for vitreomacular traction and macular hole: a prospective spectral-domain optical coherence tomography study

机译:玻璃体眼球囊溶素用于玻璃体牵引和黄斑裂孔的并发症:前瞻性光谱域光学相干层析成像研究

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Objective: The purpose of this study was to evaluate the safety of intravitreal ocriplasmin prospectively, reporting potential complications in patients with vitreomacular traction (VMT) alone or associated with macular hole (MH).Materials and methods: Participants in this prospective, multicenter study, were 24 patients with VMT (17 with VMT alone and seven with MH combined with VMT). All patients were treated with a single ocriplasmin injection and followed-up prospectively at baseline, day 7, 28 and the last examination of the follow-up for each patient (meanSD: 64.224.4 d, range: 40-145 d). Best-corrected visual acuity (BCVA) was assessed, and spectral-domain optical coherence tomography was performed at each visit while the percentage of resolution of VMT and the association with various potential adverse events were recorded and analyzed.Results: 66.7% of patients presented VMT release at the end of the follow-up, while 28.6% exhibited MH closure. Severe adverse events, such as enlargement of preexisting MH and formation of lamellar MH, were observed in one and four cases, respectively and remained till the end of the follow-up. Moderate adverse events, such as ellipsoid zone disruption and subretinal fluid development, became evident seven days after injection, in four cases. Formation of cystoid macular edema (CME), not evident at baseline, was noticed in three cases at day 28 after injection. Mild adverse events, like vitreous floaters, photopsias, eye pain and foreign body sensation, were noticed at day 7 and resolved till the end of the follow-up.Conclusions: Mild and moderate adverse events occurred mainly during the first week of the follow-up, while severe adverse events, such as the lamellar MH formation and CME at day 28 post injection were seen.
机译:目的:本研究的目的是前瞻性评估玻璃体内卵磷脂的安全性,报告玻璃体牵引(VMT)或伴有黄斑裂孔(MH)的患者的潜在并发症。材料与方法:这项前瞻性,多中心研究的参与者是24例VMT患者(其中17例单独使用VMT,7例使用MH联合VMT)。所有患者均接受单次泪cri素注射治疗,并在基线,第7天,第28天和每例患者的最后一次随访检查中进行了预期随访(平均SD:64.224.4 d,范围:40-145 d)。评估最佳矫正视力(BCVA),并在每次就诊时进行光谱域光学相干断层扫描,同时记录并分析VMT的分辨率百分比以及与各种潜在不良事件的相关性。结果:出现此病的患者占66.7%随访结束时VMT释放,而28.6%的患者则出现MH闭合。分别在1例和4例中观察到了严重的不良事件,例如先前存在的MH增大和层状MH形成,并且一直持续到随访结束。在4例患者中,注射后7天便出现了中度不良事件,例如椭球区破坏和视网膜下液发育。注射后第28天有3例在基线时没有发现囊状黄斑水肿(CME)的形成。在第7天发现了轻度不良事件,如玻璃体漂浮物,视光检查,眼痛和异物感,并一直持续到随访结束。结论:轻度和中度不良事件主要发生在随访的第一周:上升,同时观察到严重不良事件,例如注射后第28天的层状MH形成和CME。

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