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Ocriplasmin for treatment of vitreomacular traction and macular hole: A systematic literature review and individual participant data meta-analysis of randomized, controlled, double-masked trials
Survey of Ophthalmology ( IF 5.1 ) Pub Date : 2021-09-02 , DOI: 10.1016/j.survophthal.2021.08.003
Timothy L Jackson 1 , Julia Haller 2 , Koenraad H Blot 3 , Luc Duchateau 4 , Benedicte Lescrauwaet 3
Affiliation  

Ocriplasmin is used to treat vitreomacular traction (VMT), with or without full-thickness macular hole (MH). We systematically reviewed the evidence on ocriplasmin's effect on vitreomacular adhesion resolution (VMAR), MH closure, vitrectomy, and best-corrected visual acuity (BCVA) and investigated the effect of baseline covariates on outcome. We applied individual participant data meta-analyses to the entire population and to subgroups defined by MH or epiretinal membrane (ERM) presence. Safety data were pooled and tabulated. Five randomized controlled trials (1,067 participants) were included. Six months after treatment, ocriplasmin achieved higher rates of VMAR and MH closure versus control, lowered vitrectomy odds, and increased the likelihood of a ≥10-letter BCVA increase. VMAR rates were lower when ERM, broad VMA (> 1500 µm), diabetic retinopathy, or pseudophakia were present and higher in younger participants, women, and eyes with MHs. Ocriplasmin-treated participants experienced more short-term visual impairment that was not predictive of final BCVA, as well as vitreous floaters, photopsia, photophobia, eye pain, blurred vision, and dyschromatopsia. The most common serious adverse events for ocriplasmin and control, respectively, were MH progression (22.5%, 17.3%), new MH (1.5%, 3.4%) and retinal detachment (0.8%, 1.2%). Ocriplasmin promotes VMAR and MH closure. Transient visual phenomena are not uncommon.



中文翻译:

Ocriplasmin 治疗玻璃体黄斑牵引和黄斑裂孔:随机、对照、双盲试验的系统文献回顾和个体参与者数据荟萃分析

Ocriplasmin 用于治疗有或没有全层黄斑裂孔 (MH) 的玻璃体黄斑牵引 (VMT)。我们系统地回顾了 ocriplasmin 对玻璃体黄斑粘连消除 (VMAR)、MH 闭合、玻璃体切除术和最佳矫正视力 (BCVA) 影响的证据,并研究了基线协变量对结果的影响。我们将个体参与者数据荟萃分析应用于整个人群以及由 MH 或视网膜前膜 (ERM) 存在定义的亚组。将安全性数据汇总并制成表格。包括五项随机对照试验(1,067 名参与者)。治疗 6 个月后,与对照组相比,ocriplasmin 实现了更高的 VMAR 和 MH 闭合率,降低了玻璃体切除术的几率,并增加了 ≥10 个字母的 BCVA 增加的可能性。当 ERM、宽 VMA (> 1500 µm)、糖尿病视网膜病变或假晶状体在年轻参与者、女性和患有 MH 的眼睛中存在且更高。Ocriplasmin 治疗的参与者经历了更多不能预测最终 BCVA 的短期视力障碍,以及玻璃体飞蚊症、幻视、畏光、眼痛、视力模糊和色觉障碍。ocriplasmin 和对照最常见的严重不良事件分别为 MH 进展(22.5%、17.3%)、新 MH(1.5%、3.4%)和视网膜脱离(0.8%、1.2%)。Ocriplasmin 促进 VMAR 和 MH 闭合。瞬态视觉现象并不少见。畏光、眼痛、视力模糊和色觉障碍。ocriplasmin 和对照最常见的严重不良事件分别为 MH 进展(22.5%、17.3%)、新 MH(1.5%、3.4%)和视网膜脱离(0.8%、1.2%)。Ocriplasmin 促进 VMAR 和 MH 闭合。瞬态视觉现象并不少见。畏光、眼痛、视力模糊和色觉障碍。ocriplasmin 和对照最常见的严重不良事件分别为 MH 进展(22.5%、17.3%)、新 MH(1.5%、3.4%)和视网膜脱离(0.8%、1.2%)。Ocriplasmin 促进 VMAR 和 MH 闭合。瞬态视觉现象并不少见。

更新日期:2021-09-02
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