Monaco Gaspare, Gari Mariangela, Pelizzari Silvia, Lanfranchi Arianna, Ruggi Giada, Tinto Ilaria, Scialdone Antonio
Ophthalmology, Fatebenefratelli e Oftalmico Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.
Materials Science, Universita degli Studi di Milano-Bicocca, Milano, Italy.
BMJ Open Ophthalmol. 2019 Aug 15;4(1):e000280. doi: 10.1136/bmjophth-2019-000280. eCollection 2019.
To compare the performance and safety in cataract surgery of two ophthalmic viscoelastic devices (OVDs), each having separate dispersive and cohesive characteristics and different concentrations.
In this prospective, randomised, controlled clinical study, one eye of each patient was injected with OVD1 (Viscopack14) or OVD2 (DuoVisc) during phacoemulsification and intraocular lens implantation. Endothelial cell count, intraocular pressure (IOP), central corneal thickness (CCT), intraocular inflammation and corrected distance visual acuity (CDVA) were compared 3 months postoperatively.
The study enrolled 127 patients. Randomisation assigned 50 eyes of as many patients to each arm of the study. The postoperative mean endothelial cell loss was 14.4% and 7.1% from baseline in the OVD1 and OVD2 groups, respectively (p=0.08). The incidence of IOP spikes at 2 hours was 0% and 8%, respectively (p=0.02). There were intergroup differences in postoperative IOP values, the OVD2 group showed significantly higher values at all of the follow-up visits starting from the 24 hours examination (p<0.05). There was no statistically significant difference in the CCT, intraocular inflammation and CDVA at the end of follow-up.
Both OVDs showed similar clinical performances and were equally effective during cataract surgery. Viscopack14 showed more corneal endothelial cell reduction, while DuoVisc had more occurrences of IOP values and spikes. Future studies are mandatory to support these preliminary results.
比较两种眼科粘弹剂(OVDs)在白内障手术中的性能和安全性,这两种粘弹剂分别具有不同的分散性和粘性特征以及不同的浓度。
在这项前瞻性、随机、对照临床研究中,每位患者的一只眼睛在超声乳化白内障吸除术和人工晶状体植入术中注射OVD1(Viscopack14)或OVD2(DuoVisc)。术后3个月比较内皮细胞计数、眼压(IOP)、中央角膜厚度(CCT)、眼内炎症和矫正远视力(CDVA)。
该研究纳入了127例患者。随机分组将50例患者的50只眼分配到研究的每个组。OVD1组和OVD2组术后平均内皮细胞损失分别为基线的14.4%和7.1%(p = 0.08)。2小时时IOP峰值的发生率分别为零和8%(p = 0.02)。术后IOP值存在组间差异,从24小时检查开始,OVD2组在所有随访中显示出明显更高的值(p < 0.05)。随访结束时CCT、眼内炎症和CDVA无统计学显著差异。
两种OVDs在白内障手术中表现出相似的临床性能且同样有效。Viscopack14导致更多的角膜内皮细胞减少,而DuoVisc有更多的IOP值及峰值出现。未来必须开展研究以支持这些初步结果。