National Institute for Health Research Moorfields Biomedical Research Centre, Moorfields Eye Hospital and University College London Institute of Ophthalmology, London, United Kingdom.
Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom.
JAMA Ophthalmol. 2019 Jun 1;137(6):626-631. doi: 10.1001/jamaophthalmol.2019.0440.
Threshold of retinal nonperfusion for the development of proliferative diabetic retinopathy (PDR) is unclear.
To identify a threshold of retinal nonperfusion for the presence of retinal neovascularization and the distribution and area of retinal nonperfusion in eyes with severe nonproliferative diabetic retinopathy (NPDR), PDR, neovascularization of the optic disc (NVD), and retinal neovascularization elsewhere (NVE).
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional image analysis study was performed between September 24, 2018, and October 24, 2018, at a multicenter national study in the United Kingdom. Baseline images were obtained from 2 completed randomized clinical trials (Ranibizumab for Diabetic Macular Edema Panretinal Photocoagulation [RDP] study and Clinical Efficacy of Intravitreal Aflibercept vs Panretinal Photocoagulation for Best Corrected Visual Acuity in Patients With Proliferative Diabetic Retinopathy at 52 Weeks [CLARITY] study). The RDP study recruited eyes with severe NPDR between April 1, 2014, and December 31, 2015, and the CLARITY study recruited eyes with PDR between August 22, 2014, and November 20, 2015. Ultra-widefield angiography images of eyes with no prior panretinal photocoagulation treatment were included.
The total area of retinal nonperfusion, the area of posterior pole retinal nonperfusion, and the area of peripheral retinal nonperfusion were measured.
A total of 92 patients (92 eyes) were included in the study: 59 in the PDR group (mean [SD] age, 42 [15] years; 20 female [33.9%]) and 33 in the NPDR group (mean [SD] age, 63 [10] years; 3 female [9.1%]). Forty eyes had NVE and 19 had NVD with or without NVE. We identified a retinal nonperfusion threshold of 118.3 disc areas (DA) with a specificity of 84.9% (95% CI, 68.1% to 94.9%) for PDR. The median area of retinal nonperfusion was 67.8 DA (95% CI, 44.2 to 107.3 DA) in the NPDR eyes and 147.9 DA (95% CI, 127.4 to 173.5 DA) for eyes with proliferative changes, with a difference of 69.0 DA (95% CI, 42.2 to 97.7 DA; P < .001). No difference was found in the median area of posterior nonperfusion between NPDR and PDR, with a difference of 0 DA (95% CI, -6.7 to 5.2 DA; P = .56). As for peripheral nonperfusion, NPDR eyes measured 64.1 DA and PDR eyes measured 130.6 DA, with a difference of 70.8 DA (95% CI, 48.4 to 94.9 DA; P < .001). Eyes with NVD had the largest total area of retinal nonperfusion, with a difference of 65.1 DA (95% CI, 28.6 to 95.8 DA; P < .001) compared with eyes with only NVE.
These findings suggest eyes with at least 107.3 DA of nonperfusion are at risk of proliferative disease, and eyes with NVD have the largest area of retinal nonperfusion.
重要性：视网膜无灌注阈值与增生性糖尿病视网膜病变（PDR）的发展有关，但其具体数值仍不明确。
目的：本研究旨在确定视网膜无灌注的阈值，以明确其与视网膜新生血管（NV）的存在以及严重非增生性糖尿病视网膜病变（NPDR）、PDR、视盘新生血管（NVD）和其他部位视网膜新生血管（NVE）患者的视网膜 NV 分布和面积之间的关系。
设计、地点和参与者：本横断面图像分析研究于 2018 年 9 月 24 日至 10 月 24 日在英国进行，参与者来自两个多中心全国性研究（Ranibizumab for Diabetic Macular Edema Panretinal Photocoagulation [RDP] 研究和Intravitreal Aflibercept vs Panretinal Photocoagulation for Best Corrected Visual Acuity in Patients With Proliferative Diabetic Retinopathy at 52 Weeks [CLARITY] 研究）。RDP 研究纳入了 2014 年 4 月 1 日至 2015 年 12 月 31 日之间确诊严重 NPDR 的患者，CLARITY 研究纳入了 2014 年 8 月 22 日至 2015 年 11 月 20 日之间确诊 PDR 的患者。本研究纳入了未经全视网膜光凝治疗的患者的超广角血管造影图像。
主要结果和测量指标：测量视网膜无灌注的总面积、后极部视网膜无灌注的面积和周边部视网膜无灌注的面积。
结果：本研究共纳入 92 名患者（92 只眼）：PDR 组 59 名患者（平均年龄 42 岁±15 岁，女性 20 名[33.9%]），NPDR 组 33 名患者（平均年龄 63 岁±10 岁，女性 3 名[9.1%]）。40 只眼有 NVE，19 只眼有 NVD，伴或不伴 NVE。我们确定了一个视网膜无灌注阈值为 118.3 个视盘区（DA），其特异性为 84.9%（95%CI，68.1%94.9%），用于诊断 PDR。NPDR 组的视网膜无灌注中位面积为 67.8 DA（95%CI，44.2107.3 DA），增殖性改变组的视网膜无灌注中位面积为 147.9 DA（95%CI，127.4173.5 DA），差异为 69.0 DA（95%CI，42.297.7 DA；P < .001）。NPDR 组和 PDR 组的后极部无灌注面积中位数无差异，差异为 0 DA（95%CI，-6.75.2 DA；P = .56）。对于周边无灌注，NPDR 组为 64.1 DA，PDR 组为 130.6 DA，差异为 70.8 DA（95%CI，48.494.9 DA；P < .001）。有 NVD 的眼总视网膜无灌注面积最大，差异为 65.1 DA（95%CI，28.6~95.8 DA；P < .001），与仅有 NVE 的眼相比。
结论：这些发现表明，无灌注面积至少为 107.3 DA 的眼可能有发生增生性疾病的风险，而有 NVD 的眼总视网膜无灌注面积最大。
