Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany.
Acta Ophthalmol. 2013 Nov;91(7):e529-36. doi: 10.1111/aos.12153. Epub 2013 May 7.
PURPOSE: To evaluate macular morphology and function in diabetic macular edema (DME) over the course of intravitreal anti-vascular endothelial growth factor (VEGF) treatment with Ranibizumab. METHODS: A consecutive series of 39 study eyes with centre-involving DME were included in this study. In all subjects, best-corrected visual acuity (BCVA) according ETDRS protocol, fluorescein angiography (FA), microperimetric macular sensitivity (MP) and Spectral Domain optical coherence tomography (SD-OCT) cross-sectional scans were obtained before treatment and after 3 monthly applied intravitreal Ranibizumab injections. Six different morphological qualities [IS/OS layer integrity, outer nuclear layer (ONL) cysts, ONL cyst size, inner nuclear layer (INL) cysts, blocking phenomenon and subretinal fluid] were graded of each cross-sectional OCT scan before and over the course of treatment by two experienced graders. Correlation analyses between functional and morphological parameters were obtained. RESULTS: Mean BCVA increased from 26 ± 14 to 33 ± 13 letters after 3 consecutive monthly applied Ranibizumab injections (p < 0.001). Central retinal thickness (CRT) decreased from 504 ± 144 to 387 ± 122 μm (p < 0.001). Over the course of treatment, IS/OS continuity improved (index: 0.56 ± 0.52 to 0.43 ± 0.49, Z = -1.415, p = 0.157), ONL cyst prevalence and size decreased significantly (index: 0.61 ± 0.44 to 0.56 ± 0.35, Z = -3.41, p = 0.001 and 1.75 ± 0.88 to 1.17 ± 1.05, Z = -4.02, p < 0.001), INL cyst prevalence decreased (index: 0.35 ± 0.52 to 0.28 ± 0.52, Z = -1.60, p = 0.109), blocking phenomenon did not change significantly (index: 00.12 ± 0.16 to 0.13 ± 0.15, Z = -0.45, p = 0.656) and subretinal fluid almost disappeared (index: 0.10 ± 0.24 vs. 0.00 ± 0.01, Z = -2.56, p = 0.011). Correlation analyses revealed highest significant correlations between ONL cyst prevalence and their size and CRT as well as BCVA and MP before treatment and over the course of treatment. CONCLUSIONS: ONL cysts and their size as morphological parameters correlate with retinal function measured with BCVA and microperimetry before and over the course of anti-VEGF therapy with Ranibizumab in patients with DME.
目的：评估玻璃体内抗血管内皮生长因子（VEGF）治疗Ranibizumab 治疗糖尿病性黄斑水肿（DME）过程中的黄斑形态和功能。
方法：本研究纳入了 39 只中心性 DME 研究眼的连续系列。在所有受试者中，均根据 ETDRS 方案、荧光素血管造影（FA）、微视野黄斑敏感性（MP）和谱域光学相干断层扫描（SD-OCT）进行最佳矫正视力（BCVA），并在治疗前和 3 个月后获得横截面 OCT 扫描。两名经验丰富的评分员对每个横截面 OCT 扫描的 6 种不同形态质量[IS/OS 层完整性、外核层（ONL）囊肿、ONL 囊肿大小、内核层（INL）囊肿、阻塞现象和视网膜下液]进行分级。获得功能和形态参数之间的相关分析。
结果：连续 3 次每月应用 Ranibizumab 注射后，平均 BCVA 从 26 ± 14 增加到 33 ± 13 个字母（p < 0.001）。中央视网膜厚度（CRT）从 504 ± 144 降至 387 ± 122 μm（p < 0.001）。在治疗过程中，IS/OS 连续性改善（指数：0.56 ± 0.52 至 0.43 ± 0.49，Z = -1.415，p = 0.157），ONL 囊肿的发生率和大小显著降低（指数：0.61 ± 0.44 至 0.56 ± 0.35，Z = -3.41，p = 0.001 和 1.75 ± 0.88 至 1.17 ± 1.05，Z = -4.02，p < 0.001），INL 囊肿的发生率降低（指数：0.35 ± 0.52 至 0.28 ± 0.52，Z = -1.60，p = 0.109），阻塞现象无明显变化（指数：00.12 ± 0.16 至 0.13 ± 0.15，Z = -0.45，p = 0.656），视网膜下液几乎消失（指数：0.10 ± 0.24 与 0.00 ± 0.01，Z = -2.56，p = 0.011）。相关性分析显示，在治疗前和治疗过程中，ONL 囊肿的发生率及其大小与 CRT 以及 BCVA 和 MP 之间存在最高显著相关性。
结论：在 DME 患者中，抗 VEGF 治疗 Ranibizumab 治疗过程中，ONL 囊肿及其大小等形态学参数与视网膜功能（通过 BCVA 和微视野测量）相关。
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