Lubiński Wojciech, Charabin Tomasz, Podborączyńska-Jodko Karolina, Mularczyk Maciej, Lachowicz-Gosławska Ewelina
II Department of Ophthalmology, Pomeranian Medical University, Szczecin, Poland.
Chair and Department of Human and Clinical Anatomy, Pomeranian Medical University, Szczecin, Poland.
Acta Ophthalmol. 2025 Nov;103(7):e456-e471. doi: 10.1111/aos.17526. Epub 2025 May 23.
To analyse the clinical benefits of using the NGENUITY 3D Visualization System in vitreoretinal surgery with low levels of endoillumination, focusing on functional and structural retinal protection in patients with idiopathic epiretinal membranes (ERM).
Prospective, randomized, comparative study.
Forty pseudophakic patients (29♀, 11♂; age 60-80 years) with ERM underwent 27G pars plana vitrectomy (PPV) and were randomly divided into two groups: Group I (20 eyes, 3D heads-up NGENUITY system, endoillumination 0.5 Lm) and Group II (20 eyes, standard microscope [Hi-R 900], endoillumination 3.2 Lm). Preoperative and 6-months postoperative evaluations included slit-lamp examination, intraocular pressure (IOP, Pascal tonometer), Distance Best Corrected Visual Acuity (DBCVA, logMAR), Central Subfoveal Thickness (CST), Retinal Nerve Fibre Layer Thickness (RNFL, OCT), Pattern ERG (PERG), multifocal ERG (mfERG), flash ERG (ERG, ISCEV standards), and retinal sensitivity (HFA macula test). Surgery time, xenon light exposure, ERM/ILM peeling time, fundus autofluorescence (FAF), metamorphopsia incidence, and intra-/postoperative adverse events were analysed. Results were statistically evaluated (p < 0.05).
Slit-lamp examination and IOP results were normal in both groups. DBCVA improved significantly (p = 0.005) in both groups but was better for Group I, albeit not statistically significant. CST and RNFL thickness decreased significantly in both groups (p = 0.01) and did not differ between them. In Group I, increased cone and ganglion cell function was registered, with PERG showing significantly higher increases in P50 and N95 wave amplitudes (p = 0.01) compared with Group II. In mfERG, an increase in P1-wave response density in Ring 1 (p = 0.01) was observed only in Group I. In ERG, Group I showed better rod (Ab, p = 0.04), cone (Aa, p = 0.03), and amacrine cell (scotopic OPS ∑A01 + A02 + A03, p = 0.02) function compared with Group II. Foveal threshold in the HFA macula test increased significantly only in Group I (p = 0.03). No significant differences were found in autofluorescence results, surgery times, xenon light exposure, or ERM and ILM peeling times between groups. Postoperatively, the frequency of absent or reduced severity of metamorphopsia was higher in Group I (71.4%) compared with Group II (61.5%). No intraoperative or postoperative adverse events occurred.
Our preliminary results suggest that in patients with idiopathic ERM, 6 months after PPV using the NGENUITY 3D system with low levels of endoillumination, better retinal function was achieved compared with the standard PPV procedure, possibly due to reduced retinal phototoxicity. Further long-term studies are necessary to confirm that conclusion.
分析在低水平眼内照明的玻璃体视网膜手术中使用NGENUITY 3D可视化系统的临床益处,重点关注特发性视网膜前膜(ERM)患者的视网膜功能和结构保护。
前瞻性、随机、对照研究。
40例患有ERM的假晶状体患者(29例女性,11例男性;年龄60 - 80岁)接受了27G经平坦部玻璃体切除术(PPV),并随机分为两组:第一组(20只眼,3D平视NGENUITY系统,眼内照明0.5勒克斯)和第二组(20只眼,标准显微镜[Hi - R 900],眼内照明3.2勒克斯)。术前和术后6个月的评估包括裂隙灯检查、眼压(IOP,帕斯卡眼压计)、最佳矫正远视力(DBCVA,logMAR)、中心凹下厚度(CST)、视网膜神经纤维层厚度(RNFL,光学相干断层扫描)、图形视网膜电图(PERG)、多焦视网膜电图(mfERG)、闪光视网膜电图(ERG,国际临床视觉电生理学会标准)和视网膜敏感度(HFA黄斑测试)。分析手术时间、氙光暴露时间、ERM/内界膜剥除时间、眼底自发荧光(FAF)、视物变形发生率以及术中/术后不良事件。对结果进行统计学评估(p < 0.05)。
两组的裂隙灯检查和眼压结果均正常。两组的DBCVA均显著改善(p = 0.005),但第一组更好,尽管差异无统计学意义。两组的CST和RNFL厚度均显著降低(p = 0.01),且两组之间无差异。在第一组中,视锥细胞和神经节细胞功能增强,与第二组相比,PERG显示P50和N95波振幅显著更高的增加(p = 0.01)。在mfERG中,仅在第一组中观察到环1中P1波反应密度增加(p = 0.01)。在ERG中,与第二组相比,第一组显示出更好的视杆细胞(Ab,p = 0.04)、视锥细胞(Aa,p = 0.03)和无长突细胞(暗视OPS∑A01 + A02 + A03,p = 0.02)功能。HFA黄斑测试中的黄斑阈值仅在第一组中显著增加(p = 0.03)。两组之间在自发荧光结果、手术时间、氙光暴露时间或ERM和内界膜剥除时间方面未发现显著差异。术后,第一组视物变形缺失或严重程度降低的频率高于第二组(71.4%对61.5%)。未发生术中或术后不良事件。
我们的初步结果表明,在特发性ERM患者中,使用低水平眼内照明的NGENUITY 3D系统进行PPV术后6个月,与标准PPV手术相比,视网膜功能更好,这可能是由于视网膜光毒性降低。需要进一步的长期研究来证实这一结论。