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DOI10.1136/bmjophth-2020-000648
Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial
Velaga, Swetha Bindu; Nittala, Muneeswar Gupta; Ip, Michael S.; Duchateau, Luc; Sadda, SriniVas R.
通讯作者Sadda, SR (corresponding author), Doheny Eye Inst, Retina, 1355 San Pablo St, Los Angeles, CA 90033 USA. ; Sadda, SR (corresponding author), Univ Calif Los Angeles, David Geffen Sch Med, Ophthalmol, Pasadena, CA 90095 USA. ; Sadda, SR (corresponding author), Univ Calif Los Angeles, Ophthalmol, Los Angeles, CA 90024 USA.
来源期刊BMJ OPEN OPHTHALMOLOGY
ISSN2397-3269
出版年2021
卷号6期号:1
英文摘要Background/aims OASIS is a Phase IIIb trial (NCT01429441) assessing long-term outcomes in subjects with symptomatic vitreomacular adhesion (VMA). The purpose of this study is to report on the frequency, severity, location and time course of ellipsoid zone (EZ) alterations in ocriplasmin-treated and sham control eyes in the OASIS study. Methods 220 patients (146 ocriplasmin, 74 sham) subjects with VMA were enrolled in this masked post hoc analysis phase IIIb, randomised, sham-controlled double-masked multicentre clinical trial. A masked post hoc analysis of OCT images was performed at the Doheny Image Reading Center from subjects enrolled in the OASIS trial. The status of the EZ band was assessed in three different macular regions: the central subfield (CS) (<= 1 mm diameter), the parafoveal area (PAA) (>1 to <= 3 mm) and the perifoveal area (PEA) (>3 to <= 6 mm). The EZ band was rated as normal/intact, full thickness macular hole (FTMH), abnormal but continuous, discontinuous/disrupted or absent at visits from baseline (pretreatment) to week 1 (day 7), month 1 (day 28), month 3, month 6, month 12 and the final follow-up at month 24. EZ band status was compared in both study and control eyes. Results A total of 208 patients (138 ocriplasmin, 70 sham) were included in this analysis. At baseline, FTMH was present in 48.6%, 8.0%, 0% and 52.8%, 2.9%, 0% in the CS, PAA and PEA of the ocriplasmin and sham groups, respectively. The EZ was graded to be abnormal but continuous, discontinuous/disrupted or absent at Baseline in 21.0%, 4.3%, 2.8% in the CS, PAA and PEA, respectively, of the ocriplasmin group; and 12.9%, 10.0%, 4.3% in the CS, PAA and PEA of the sham group. For the ocriplasmin group in the PAA, this frequency increased to 6.6% at week 1, was 9.8% at month 1, but improved to 3.8% at month 3, and remained stable to 1.6% at month 24. These differences, however, were not statistically significant. Conclusions Ocriplasmin treatment for symptomatic VMA was associated with EZ abnormalities in a small percentage of patients that was best assessed in regions (PEA) relatively unaffected by the VM interface disease at baseline. The EZ abnormalities were apparent by week 1, persisted at month 1, and appeared to resolve in the majority of cases by month 3.
英文关键词vitreous retina clinical trial Treatment other
类型Article
语种英语
开放获取类型gold, Green Published
收录类别ESCI
WOS记录号WOS:000688256300002
WOS关键词INTRAVITREAL OCRIPLASMIN ; MACULAR HOLE ; VISION LOSS ; TRACTION
WOS类目Ophthalmology
WOS研究方向Ophthalmology
来源机构University of California, Los Angeles
资源类型期刊论文
条目标识符http://119.78.100.177/qdio/handle/2XILL650/362730
作者单位[Velaga, Swetha Bindu; Sadda, SriniVas R.] Doheny Eye Inst, Retina, 1355 San Pablo St, Los Angeles, CA 90033 USA; [Velaga, Swetha Bindu; Nittala, Muneeswar Gupta] Univ Calif Los Angeles, Doheny Eye Inst, Ophthalmol, Los Angeles, CA USA; [Nittala, Muneeswar Gupta; Ip, Michael S.; Sadda, SriniVas R.] Univ Calif Los Angeles, David Geffen Sch Med, Ophthalmol, Pasadena, CA 90095 USA; [Duchateau, Luc] Univ Ghent, Biometr Res Ctr, Ghent, Belgium; [Sadda, SriniVas R.] Univ Calif Los Angeles, Ophthalmol, Los Angeles, CA 90024 USA
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Velaga, Swetha Bindu,Nittala, Muneeswar Gupta,Ip, Michael S.,et al. Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial[J]. University of California, Los Angeles,2021,6(1).
APA Velaga, Swetha Bindu,Nittala, Muneeswar Gupta,Ip, Michael S.,Duchateau, Luc,&Sadda, SriniVas R..(2021).Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial.BMJ OPEN OPHTHALMOLOGY,6(1).
MLA Velaga, Swetha Bindu,et al."Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial".BMJ OPEN OPHTHALMOLOGY 6.1(2021).
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