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前瞻性观察性 ORBIT 试验中注射 ocriplasmin 后纵向椭圆带和视网膜下液的定位。

Longitudinal ellipsoid zone and subretinal fluid mapping following ocriplasmin injection in the prospective observational ORBIT trial.

机构信息

Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States.

Department of Ophthalmology, Northwestern University, Chicago, Illinois, United States.

出版信息

Br J Ophthalmol. 2020 Mar;104(3):410-415. doi: 10.1136/bjophthalmol-2019-314142. Epub 2019 Jun 27.

DOI:10.1136/bjophthalmol-2019-314142
PMID:31248879
Abstract

BACKGROUND

Ocriplasmin is approved for the treatment of symptomatic vitreomacular traction (VMT). However, several retrospective reports have identified ellipsoid zone (EZ) alterations on spectral domain optical coherence tomography (SDOCT) after ocriplasmin injection. This report quantitatively analysed outer retinal changes after intravitreal ocriplasmin.

METHODS

Ocriplasmin Research to Better Inform Treatment is a prospective, observational phase IV clinical study where subjects received a single intravitreal injection of ocriplasmin for symptomatic VMT. Macular cube scans were imported into a semiautomated EZ mapping and fluid feature extraction software for SDOCT analysis. Change in visual acuity, VMT release, macular hole (MH) closure, EZ integrity/volume and subretinal fluid (SRF) volume on SDOCT macular cube scans were recorded and analysed.

RESULTS

This analysis included 55 participants with 6 months of follow-up. Intravitreal ocriplasmin injection caused VMT release in 67% and MH closure in 82% of participants. Visual acuity improved by 4.5 letters (p<0.05) in the whole cohort and by 6.0 letters (p<0.05) in participants with VMT release. EZ volume was reduced by 23.4% at week 1 (p<0.001) and recovered to baseline by between months 3 and 6. EZ volume loss at week 1 did not correlate with ETDRS acuity at final visit.

CONCLUSION

Ocriplasmin treatment resulted in VMT release, MH closure and visual acuity gains in a significant portion of eyes. EZ volume was significantly reduced at week 1, but recovered to baseline levels by final follow-up and was not associated with final visual acuity.

摘要

背景

奥克里普斯酶(ocriplasmin)已被批准用于治疗有症状的玻璃体黄斑牵拉(VMT)。然而,几项回顾性报告指出,奥克里普斯酶注射后,在频域光学相干断层扫描(SDOCT)上出现椭圆体带(EZ)改变。本报告定量分析了玻璃体内注射奥克里普斯酶后外视网膜的变化。

方法

奥克里普斯酶治疗研究以更好地提供信息,这是一项前瞻性、观察性的 IV 期临床研究,其中受试者接受单次玻璃体内奥克里普斯酶注射治疗有症状的 VMT。将黄斑立方体扫描导入半自动化的 EZ 映射和液体特征提取软件进行 SDOCT 分析。记录和分析 SDOCT 黄斑立方体扫描上视力、VMT 松解、黄斑裂孔(MH)闭合、EZ 完整性/体积和视网膜下液(SRF)体积的变化。

结果

本分析包括 55 名接受 6 个月随访的参与者。玻璃体内奥克里普斯酶注射使 67%的参与者 VMT 松解,82%的参与者 MH 闭合。整个队列的视力提高了 4.5 个字母(p<0.05),VMT 松解的参与者提高了 6.0 个字母(p<0.05)。EZ 体积在第 1 周减少了 23.4%(p<0.001),并在第 3 至 6 个月恢复到基线。第 1 周 EZ 体积丢失与最终随访时 ETDRS 视力无关。

结论

奥克里普斯酶治疗导致 VMT 松解、MH 闭合和视力提高,在很大一部分眼中显著。EZ 体积在第 1 周明显减少,但在最终随访时恢复到基线水平,与最终视力无关。

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