Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.
Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Ophthalmol Retina. 2022 Aug;6(8):664-675. doi: 10.1016/j.oret.2022.03.010. Epub 2022 Mar 18.
To describe the frequency of long-term morphologic features and their relationships with visual function in participants who exited the Inhibition of VEGF in Age-Related Choroidal Neovascularisation (IVAN; ISRCTN92166560) trial.
Multicenter cohort study up to 7 years after enrollment.
Patients enrolled in the IVAN trial, excluding participants who died or withdrew during the trial.
Multimodal fundus images, best-corrected visual acuity (BCVA), and low-luminance visual acuity (LLVA) were obtained for a subset of 199 participants who attended a research visit. Clinical sites (n = 20) also provided all visual acuity and clinical information from usual care records for 532 participants and submitted the most recent color, OCT, and other fundus images for 468 participants to a reading center.
Assessed the following from the most recent images: intralesional macular atrophy (ILMA) within the footprint of the neovascular lesion; hyperreflective material (HRM); intraretinal fluid (IRF); subretinal fluid (SRF); pigment epithelial detachment (PED); and disorganized retinal outer layers (DROLs). Cross-sectional relationships between morphologic features and BCVA/LLVA were estimated.
Intralesional macular atrophy was present in 31.8% of the study eyes at IVAN exit (mean follow-up, 1.96 years) and 89.5% at the most recent imaging visit (mean follow-up, 6.18 years). Hyperreflective material, IRF, SRF, PED, and DROLs were present in 78.8%, 47.7%, 7.6%, 94.5%, and 55% of the study eyes, respectively. In the subset with complete imaging data, in eyes without DROL, the BCVA was worst in the thinnest outer fovea tertile (thinnest minus middle and thickest tertiles, -19.7 and -19.5 letters, respectively), whereas in eyes with DROL, the BCVA was worst in the thickest (thinnest and middle tertiles minus thickest, 12.5 and 12.2, respectively). Regression models showed that the presence of ILMA and HRM was independently associated with BCVA (22 letters worse [95% confidence interval {CI}, -11.2 to -32.8; P < 0.001] and 9.8 letters worse [95% CI, -0.1 to -19.4; P = 0.047], respectively). Subretinal fluid and foveal PED were associated with better BCVA (5.9 letters [95% CI, -7.9 to 19.7; P = 0.399] and 6.4 letters [95% CI, -1.1 to 14.0; P = 0.094], respectively). The model with LLVA was similar. A sensitivity analysis involving the entire eligible cohort yielded similar estimates.
Macular atrophy and HRM were common after 7 years of follow-up and strongly associated with visual outcomes.
描述参与抑制血管内皮生长因子治疗年龄相关性脉络膜新生血管（IVAN；ISRCTN92166560）试验退出者的长期形态特征及其与视觉功能的关系。
登记后 7 年的多中心队列研究。
排除在试验期间死亡或退出的 IVAN 试验参与者。
为参加研究访问的 199 名参与者中的一部分获得了多模态眼底图像、最佳矫正视力（BCVA）和低亮度视力（LLVA）。临床站点（n=20）还从常规护理记录中提供了 532 名参与者的所有视力和临床信息，并将 468 名参与者的最新彩色、OCT 和其他眼底图像提交给一个阅读中心。
根据最近的图像评估以下内容：新生血管病变足迹内的局灶性黄斑萎缩（ILMA）；高反射物质（HRM）；视网膜内液（IRF）；视网膜下液（SRF）；色素上皮脱离（PED）；和视网膜外层排列紊乱（DROL）。估计形态特征与 BCVA/LLVA 的横断面关系。
IVAN 退出时（平均随访 1.96 年），31.8%的研究眼存在局灶性黄斑萎缩，而最近一次影像学随访时（平均随访 6.18 年），89.5%的研究眼存在局灶性黄斑萎缩。高反射物质、IRF、SRF、PED 和 DROL 分别存在于 78.8%、47.7%、7.6%、94.5%和 55%的研究眼中。在具有完整成像数据的子集中，在没有 DROL 的眼中，最薄的外凹部三分之一的 BCVA 最差（最薄减去中间和最厚三分之一，分别为-19.7 和-19.5 个字母），而在有 DROL 的眼中，最厚的（最薄和中间三分之一减去最厚，分别为 12.5 和 12.2）。回归模型表明，ILMA 和 HRM 的存在与 BCVA 独立相关（分别差 22 个字母[95%置信区间{CI}，-11.2 至-32.8；P<0.001]和 9.8 个字母差[95%CI，-0.1 至-19.4；P=0.047]）。视网膜下液和中心凹 PED 与更好的 BCVA 相关（分别差 5.9 个字母[95%CI，-7.9 至 19.7；P=0.399]和 6.4 个字母[95%CI，-1.1 至 14.0；P=0.094]）。包含 LLVA 的模型类似。涉及整个合格队列的敏感性分析得出了类似的估计值。
在 7 年的随访后，黄斑萎缩和 HRM 很常见，并且与视觉结果密切相关。
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