Folgar Francisco A, Jaffe Glenn J, Toth Cynthia A, Mahmoud Tamer H
Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina; Carolina Eyecare Physicians, Charleston, South Carolina.
Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.
Ophthalmol Retina. 2017 May-Jun;1(3):240-248. doi: 10.1016/j.oret.2016.11.013. Epub 2017 Feb 2.
To compare foveal anatomic features on OCT after macular hole (MH) closure, and their association with visual function, in the ocriplasmin phase III trials.
Randomized clinical trial.
One hundred fifty-three participants.
Each participant had 1 eye with baseline MH randomized to single intravitreal injection of placebo or ocriplasmin. After enrollment in 1 of the 2 nonsurgical treatment groups, a subset of eyes were analyzed in a surgical treatment group that had pars plana vitrectomy (PPV) after placebo or ocriplasmin.
Subfoveal lucency after MH closure was graded on time-domain OCT (TD-OCT) at all visits, and was compared with visual acuity (VA) and fluorescein angiography (FA) leakage at the final study visit. In a subset of visits with spectral-domain OCT (SD-OCT), subfoveal lucency, ellipsoid zone (EZ), and external limiting membrane (ELM) defects were graded and measured.
Eyes in the placebo, ocriplasmin, and PPV groups with MH closure 1 month after treatment had subfoveal lucency in 5 of 5 (100%), 42 of 43 (98%), and 8 of 37 (22%) eyes, respectively; and eyes with MH closure 6 months after treatment had subfoveal lucency in 3 of 8 (38%), 30 of 44 (68%), and 11 of 60 (18%) eyes, respectively. Resolution of subfoveal lucency lagged behind EZ and ELM recovery in the ocriplasmin group, whereas it preceded EZ and ELM recovery in the PPV group. Subfoveal lucency base width increased after MH closure with ocriplasmin (+662±139 μm) but decreased after placebo (-255±154 μm) and PPV (-777±243 μm), when compared with pretreatment MH base width. Subfoveal lucency was not associated with FA leakage or VA outcomes in any treatment group.
After MH closure with ocriplasmin, subfoveal lucency width was greater than pretreatment MH and persisted longer during follow-up compared with placebo or PPV. Subfoveal lucency was not a marker for visual function regardless of treatment group.
在ocriplasmin的III期试验中，比较黄斑裂孔（MH）闭合后光学相干断层扫描（OCT）上的黄斑中心凹解剖特征及其与视功能的关系。
随机临床试验。
153名参与者。
每位参与者有1只基线存在MH的眼睛，被随机分配接受玻璃体内单次注射安慰剂或ocriplasmin。在纳入2个非手术治疗组中的1组后，对一部分眼睛进行分析，这些眼睛在接受安慰剂或ocriplasmin治疗后接受了玻璃体视网膜手术（PPV）。
在所有随访时，根据时域OCT（TD - OCT）对MH闭合后的黄斑中心凹清晰度进行分级，并在最终研究随访时与视力（VA）和荧光素血管造影（FA）渗漏情况进行比较。在一部分使用光谱域OCT（SD - OCT）的随访中，对黄斑中心凹清晰度、椭圆体带（EZ）和外界膜（ELM）缺陷进行分级和测量。
治疗后1个月MH闭合的安慰剂组、ocriplasmin组和PPV组的眼睛中，分别有5/5（100%）、42/43（98%）和8/37（22%）的眼睛存在黄斑中心凹清晰度；治疗后6个月MH闭合的眼睛中，分别有3/8（38%）、30/44（68%）和11/60（18%）的眼睛存在黄斑中心凹清晰度。在ocriplasmin组中，黄斑中心凹清晰度的消退落后于EZ和ELM的恢复，而在PPV组中则先于EZ和ELM的恢复。与治疗前MH底部宽度相比，ocriplasmin治疗后MH闭合时黄斑中心凹清晰度底部宽度增加（+662±139μm），而安慰剂（-255±154μm）和PPV（-777±243μm）治疗后则减小。在任何治疗组中，黄斑中心凹清晰度与FA渗漏或VA结果均无关联。
与安慰剂或PPV相比，ocriplasmin治疗MH闭合后，黄斑中心凹清晰度宽度大于治疗前MH，且在随访期间持续时间更长。无论治疗组如何，黄斑中心凹清晰度都不是视功能的标志物。
