PDF(Pubmed)
Abstract：
UNASSIGNED: To assess generalized (GD) and focal ellipsoid zone disruption (FD) in patients with symptomatic vitreomacular adhesion (sVMA) using spectral domain optical coherence tomography (SD-OCT) following ocriplasmin.
UNASSIGNED: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg). Data from adult patients with at least 6-month follow-up after ocriplasmin were included. SD-OCT was performed at baseline (within 30 days before ocriplasmin), before Day 21 post-injection (early observation, EO), and by last observation (LO) which was maximally 6 months post-injection. The main outcome measure was the development of new and the evolution of existing FD/GD at EO and LO.
UNASSIGNED: The study enrolled 134 eyes/patients from 22 sites in the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) had no FD/GD. Among the eyes without FD/GD at baseline, 13 (50%) and 8 (30.8%) developed FD or GD, respectively, by EO. By LO, FD/GD improvement or resolution was seen in >80% of these eyes. Among the eyes with FD/GD at baseline, <40% had improving/resolving EZ integrity at LO. The absence of FD/GD at baseline was associated with less persistent FD/GD at LO (P<0.0005). The presence of FD with MH at baseline was associated with persistent FD at LO (P=0.027).
UNASSIGNED: The fact that a large majority of eyes had FD/GD prior to ocriplasmin was unexpected and demonstrates that EZ disruptions are common in sVMA. This suggests that loss of EZ integrity may be part of the natural history of this disorder. It is hypothesized that the status of the EZ at baseline is a contributing, ocriplasmin independent modulator of subsequent EZ changes after ocriplasmin. Prospective analyses which include a sham control group would be required to test this hypothesis.
UNASSIGNED: OZONE was a Phase 4, retrospective study of patients with sVMA treated with a single intravitreal injection of ocriplasmin (0.125 mg). Data from adult patients with at least 6-month follow-up after ocriplasmin were included. SD-OCT was performed at baseline (within 30 days before ocriplasmin), before Day 21 post-injection (early observation, EO), and by last observation (LO) which was maximally 6 months post-injection. The main outcome measure was the development of new and the evolution of existing FD/GD at EO and LO.
UNASSIGNED: The study enrolled 134 eyes/patients from 22 sites in the USA. At baseline, 87 eyes (64.9%) had FD, 21 eyes (15.7%) had GD and 26 eyes (19.4%) had no FD/GD. Among the eyes without FD/GD at baseline, 13 (50%) and 8 (30.8%) developed FD or GD, respectively, by EO. By LO, FD/GD improvement or resolution was seen in >80% of these eyes. Among the eyes with FD/GD at baseline, <40% had improving/resolving EZ integrity at LO. The absence of FD/GD at baseline was associated with less persistent FD/GD at LO (P<0.0005). The presence of FD with MH at baseline was associated with persistent FD at LO (P=0.027).
UNASSIGNED: The fact that a large majority of eyes had FD/GD prior to ocriplasmin was unexpected and demonstrates that EZ disruptions are common in sVMA. This suggests that loss of EZ integrity may be part of the natural history of this disorder. It is hypothesized that the status of the EZ at baseline is a contributing, ocriplasmin independent modulator of subsequent EZ changes after ocriplasmin. Prospective analyses which include a sham control group would be required to test this hypothesis.
摘要：
■使用光谱域光学相干断层扫描（SD-OCT）评估有症状的玻璃体黄斑粘连（sVMA）患者的广泛性（GD）和局灶性椭圆形区破裂（FD）。
■OZONE是sVMA患者的4期回顾性研究，该研究采用玻璃体内单次注射ocriplasmin（0.125mg）治疗。包括来自成年患者的数据，这些患者在ocriplasmin后至少进行了6个月的随访。SD-OCT在基线时（在ocriplasmin前30天内）进行，注射后第21天之前(早期观察，EO),最后一次观察（LO），最大为注射后6个月。主要结果指标是EO和LO的新FD/GD的开发和现有FD/GD的演变。
■该研究纳入了来自美国22个地点的134只眼/患者。在基线,87只眼睛（64.9%）有FD，21只眼（15.7%）有GD，26只眼（19.4%）无FD/GD。在基线无FD/GD的眼睛中，13(50%)和8(30.8%)出现FD或GD，分别,通过EO。ByLO,在>80%的这些眼睛中观察到FD/GD改善或分辨率。在基线有FD/GD的眼睛中，<40%具有在LO下改善/解决的EZ完整性。基线时没有FD/GD与LO时持续性FD/GD减少相关(P<0.0005)。基线时MHFD的存在与LO时持续性FD相关(P=0.027)。
■大多数眼睛在ocriplasmin之前患有FD/GD的事实是出乎意料的，并表明EZ破坏在sVMA中很常见。这表明EZ完整性的丧失可能是这种疾病的自然史的一部分。假设EZ在基线时的状态是一个贡献，奥氏酶独立于奥氏酶后随后EZ变化的调节剂。需要包括假对照组的前瞻性分析来检验这一假设。
■OZONE是sVMA患者的4期回顾性研究，该研究采用玻璃体内单次注射ocriplasmin（0.125mg）治疗。包括来自成年患者的数据，这些患者在ocriplasmin后至少进行了6个月的随访。SD-OCT在基线时（在ocriplasmin前30天内）进行，注射后第21天之前(早期观察，EO),最后一次观察（LO），最大为注射后6个月。主要结果指标是EO和LO的新FD/GD的开发和现有FD/GD的演变。
■该研究纳入了来自美国22个地点的134只眼/患者。在基线,87只眼睛（64.9%）有FD，21只眼（15.7%）有GD，26只眼（19.4%）无FD/GD。在基线无FD/GD的眼睛中，13(50%)和8(30.8%)出现FD或GD，分别,通过EO。ByLO,在>80%的这些眼睛中观察到FD/GD改善或分辨率。在基线有FD/GD的眼睛中，<40%具有在LO下改善/解决的EZ完整性。基线时没有FD/GD与LO时持续性FD/GD减少相关(P<0.0005)。基线时MHFD的存在与LO时持续性FD相关(P=0.027)。
■大多数眼睛在ocriplasmin之前患有FD/GD的事实是出乎意料的，并表明EZ破坏在sVMA中很常见。这表明EZ完整性的丧失可能是这种疾病的自然史的一部分。假设EZ在基线时的状态是一个贡献，奥氏酶独立于奥氏酶后随后EZ变化的调节剂。需要包括假对照组的前瞻性分析来检验这一假设。
