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Abstract：
OBJECTIVE: Effectiveness of ocriplasmin for vitreomacular traction (VMT) varies depending on the presence of common ocular conditions and patient selection criteria. We carried out a systematic literature review and meta-analysis of ocriplasmin studies conducted in real-world settings (RWS) and compared outcomes with those from randomized controlled trials (RCTs).
METHODS: We included prospective and retrospective studies from RWS documenting effectiveness of ocriplasmin in patients with VMT with or without MH, and RCTs of ocriplasmin versus control. Key end-points were vitreomacular adhesion resolution (VMAR), nonsurgical MH closure, need for vitrectomy and safety. We conducted meta-regression on pooled results to evaluate effects of baseline covariates and study design on outcomes.
RESULTS: Thirty RWS (2402 patients) and 5 RCTs (737 patients) were included epiretinal membrane (ERM) and broad VMA were more prevalent in RCTs. Primary VMAR, vitrectomy and MH closure rates were comparable between RWS and RCTs. Rates of nsVMAR were significantly higher in RWS than RCTs (odds ratio 1.66; 95% confidence interval [CI]: 1.18-2.34). nsVMAR rates were inversely associated with ERM prevalence (odds ratio 0.20; 95% CI: 0.08-0.51). Compared with the recent OASIS trial, RWS reported a higher incidence of new/worsening subretinal fluid cases and less photophobia, photopsia, vitreous floaters, electroretinogram abnormalities and MH progression.
CONCLUSIONS: Ocriplasmin was significantly more effective in achieving nsVMAR in RWS than in RCTs. Lower ERM prevalence in RWS was the single significant explanatory variable for this difference. Conclusions on ocriplasmin safety in RWS are limited due to inconsistent reporting.
METHODS: We included prospective and retrospective studies from RWS documenting effectiveness of ocriplasmin in patients with VMT with or without MH, and RCTs of ocriplasmin versus control. Key end-points were vitreomacular adhesion resolution (VMAR), nonsurgical MH closure, need for vitrectomy and safety. We conducted meta-regression on pooled results to evaluate effects of baseline covariates and study design on outcomes.
RESULTS: Thirty RWS (2402 patients) and 5 RCTs (737 patients) were included epiretinal membrane (ERM) and broad VMA were more prevalent in RCTs. Primary VMAR, vitrectomy and MH closure rates were comparable between RWS and RCTs. Rates of nsVMAR were significantly higher in RWS than RCTs (odds ratio 1.66; 95% confidence interval [CI]: 1.18-2.34). nsVMAR rates were inversely associated with ERM prevalence (odds ratio 0.20; 95% CI: 0.08-0.51). Compared with the recent OASIS trial, RWS reported a higher incidence of new/worsening subretinal fluid cases and less photophobia, photopsia, vitreous floaters, electroretinogram abnormalities and MH progression.
CONCLUSIONS: Ocriplasmin was significantly more effective in achieving nsVMAR in RWS than in RCTs. Lower ERM prevalence in RWS was the single significant explanatory variable for this difference. Conclusions on ocriplasmin safety in RWS are limited due to inconsistent reporting.
摘要：
目的：ocriasmin用于玻璃体黄斑牵引（VMT）的有效性因常见眼部疾病的存在和患者选择标准而异。我们对在现实环境（RWS）中进行的ocriplasmin研究进行了系统的文献综述和荟萃分析，并将结果与随机对照试验（RCT）的结果进行了比较。
方法：我们纳入了来自RWS的前瞻性和回顾性研究，这些研究记录了有或没有MH的VMT患者使用ocriplasmin的有效性。与对照相比，ocriplasmin的随机对照试验。关键终点是玻璃体黄斑粘连分辨率（VMAR），非手术MH闭合术，需要玻璃体切除术和安全性。我们对合并结果进行了荟萃回归，以评估基线协变量和研究设计对结局的影响。
结果：30例RWS（2402例）和5例RCT（737例）包括视网膜前膜（ERM），广泛的VMA在RCT中更为普遍。主VMAR,RWS和RCT的玻璃体切除术和MH闭合率相当.RWS的nsVMAR比率显著高于RCT(比值比1.66;95%置信区间[CI]:1.18-2.34)。nsVMAR率与ERM患病率呈负相关(比值比0.20;95%CI:0.08-0.51)。与最近的OASIS试验相比，RWS报告新的/恶化的视网膜下积液病例的发生率较高，畏光较少，验光,玻璃体漂浮物,视网膜电图异常和MH进展。
结论：Ocriplasmin在RWS中实现nsVMAR方面比在RCT中更有效。RWS中较低的ERM患病率是这一差异的单一显著解释变量。由于报告不一致，因此对RWS中ocrilasmin安全性的结论有限。
方法：我们纳入了来自RWS的前瞻性和回顾性研究，这些研究记录了有或没有MH的VMT患者使用ocriplasmin的有效性。与对照相比，ocriplasmin的随机对照试验。关键终点是玻璃体黄斑粘连分辨率（VMAR），非手术MH闭合术，需要玻璃体切除术和安全性。我们对合并结果进行了荟萃回归，以评估基线协变量和研究设计对结局的影响。
结果：30例RWS（2402例）和5例RCT（737例）包括视网膜前膜（ERM），广泛的VMA在RCT中更为普遍。主VMAR,RWS和RCT的玻璃体切除术和MH闭合率相当.RWS的nsVMAR比率显著高于RCT(比值比1.66;95%置信区间[CI]:1.18-2.34)。nsVMAR率与ERM患病率呈负相关(比值比0.20;95%CI:0.08-0.51)。与最近的OASIS试验相比，RWS报告新的/恶化的视网膜下积液病例的发生率较高，畏光较少，验光,玻璃体漂浮物,视网膜电图异常和MH进展。
结论：Ocriplasmin在RWS中实现nsVMAR方面比在RCT中更有效。RWS中较低的ERM患病率是这一差异的单一显著解释变量。由于报告不一致，因此对RWS中ocrilasmin安全性的结论有限。
