Marques Inês Pereira, Reste-Ferreira Débora, Santos Torcato, Mendes Luís, Martinho António Cunha-Vaz, Yamaguchi Taffeta Ching Ning, Santos Ana Rita, Pearce Elizabeth, Cunha-Vaz José
AIBILI - Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Coimbra Ophthalmology Reading Centre (CORC), Coimbra, Portugal.
Ophthalmol Sci. 2024 Oct 16;5(2):100632. doi: 10.1016/j.xops.2024.100632. eCollection 2025 Mar-Apr.
To evaluate the 6-month progression of retinal capillary perfusion in eyes with advanced stages of nonproliferative diabetic retinopathy (NPDR).
RICHARD (NCT05112445), 2-year prospective longitudinal study.
Sixty eyes with Diabetic Retinopathy Severity Scale (DRSS) levels 43, 47, and 53 from 60 patients with type 2 diabetes. Fifty-one patients completed the 6-month evaluation.
Eyes were evaluated on Optos California (Optos plc) ultrawidefield fundus fluorescein angiography (UWF-FFA), swept-source OCT angiography (SS-OCTA) (PLEX Elite 9000, ZEISS) and spectral-domain OCTA (SD-OCTA) (CIRRUS HD-OCT 5000 Angioplex, ZEISS). DRSS classification was performed based on 7-field color fundus photographs (CFPs) complemented with Optos California UWF-fundus imaging.
Ischemic index was obtained from Optos. Vascular quantification metrics, namely foveal avascular zone, skeletonized vessel density (SVD), and perfusion density (PD) metrics, were acquired on OCTA in the superficial and deep capillary plexuses (SCP and DCP). Microaneurysm assessment was automatically performed based on CFP images using the RetmarkerDR (Retmarker SA, Meteda Group).
Swept-source-OCTA metrics showed statistically significant differences between the advanced stages of NPDR. Differences between DRSS levels 47 and 53 were found at baseline in the inner ring (SVD, SCP: = 0.005 and DCP: = 0.042 and PD, SCP: = 0.003) and outer ring (SVD, SCP: = 0.007 and DCP: = 0.030 and PD, SCP: = 0.020 and DCP: = 0.025). No significant differences were observed at baseline between DRSS levels 43 and 47. In SD-OCTA, the differences were similar but did not reach statistical significance. The total ischemic index showed an increase in association with diabetic retinopathy (DR) severity, but the differences between DRSS levels did not reach statistical significance. The number of microaneurysms also increased significantly with DR severity ( = 0.033). Statistically significant 6-month progression was detected with SS-OCTA in eyes with DRSS levels 47 and 53 but not in DRSS level 43. In eyes with DRSS level 53, 6-month progression was identified using a combination of metrics of capillary nonperfusion and microaneurysm counts.
In a 6-month period, significant microvascular disease progression can be identified in eyes with DRSS levels 47 and 53 by performing OCTA examinations and microaneurysm counting using CFP.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估非增殖性糖尿病视网膜病变（NPDR）晚期患者眼部视网膜毛细血管灌注的6个月进展情况。
RICHARD（NCT05112445），为期2年的前瞻性纵向研究。
60例2型糖尿病患者的60只眼睛，糖尿病视网膜病变严重程度量表（DRSS）评分为43、47和53级。51例患者完成了6个月的评估。
使用Optos California（Optos plc）超广角眼底荧光血管造影（UWF-FFA）、扫频源光学相干断层扫描血管造影（SS-OCTA）（PLEX Elite 9000，蔡司）和谱域光学相干断层扫描血管造影（SD-OCTA）（CIRRUS HD-OCT 5000 Angioplex，蔡司）对眼睛进行评估。基于7视野彩色眼底照片（CFP）并辅以Optos California UWF眼底成像进行DRSS分级。
从Optos获得缺血指数。在OCTA上获取浅表和深部毛细血管丛（SCP和DCP）的血管定量指标，即中心凹无血管区、骨骼化血管密度（SVD）和灌注密度（PD）指标。使用RetmarkerDR（Retmarker SA，Meteda Group）基于CFP图像自动进行微动脉瘤评估。
扫频源光学相干断层扫描血管造影指标显示NPDR晚期之间存在统计学显著差异。在基线时，DRSS 47级和53级之间在内环（SVD，SCP：=0.005，DCP：=0.042；PD，SCP：=0.003）和外环（SVD，SCP：=0.007，DCP：=0.030；PD，SCP：=0.020，DCP：=0.025）发现差异。DRSS 43级和47级之间在基线时未观察到显著差异。在SD-OCTA中，差异相似但未达到统计学显著水平。总缺血指数显示与糖尿病视网膜病变（DR）严重程度相关增加，但DRSS级别之间的差异未达到统计学显著水平。微动脉瘤数量也随DR严重程度显著增加（=0.033）。使用SS-OCTA在DRSS 47级和53级的眼睛中检测到有统计学显著意义的6个月进展，但在DRSS 43级中未检测到。在DRSS 53级的眼睛中，使用毛细血管无灌注和微动脉瘤计数指标的组合确定了6个月进展。
在6个月期间，通过进行OCTA检查和使用CFP进行微动脉瘤计数，可以在DRSS 47级和53级的眼睛中识别出显著的微血管疾病进展。
在本文末尾的脚注和披露中可能会发现专有或商业披露信息。
