Auffarth Gerd U, Auerbach Florian N, Rabsilber Tanja, Gegúndez José A, Cuiña Ricardo, Renard Yves, Vinciguerra Paolo, Camesasca Fabrizio, Van Cauwenberge Francoise, Amzallag Thierry, Van Setten Gysbert, Holzer Mike P
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
From the University of Heidelberg (Auffarth, Auerbach, Rabsilber, Holzer), Heidelberg, Germany; Hospital Clínico San Carlos (Gegúndez, Cuiña), Madrid, Spain; Hôpital privé d'Antony (Renard), Antony, France; Istituto Clinico Humanitas (Vinciguerra, Camesasca), Rozzano, Milano, Italy; Centre Hospitalier Universitaire Sart Tilmann (Van Cauwenberge), Liège, Belgium; Clinique Institut Ophtalmologique (Amzallag), Somain, France; St. Eriks Eye Hospital (Van Setten), Stockholm, Sweden.
J Cataract Refract Surg. 2017 Jan;43(1):87-94. doi: 10.1016/j.jcrs.2016.10.025.
To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery.
European multicenter study.
Prospective randomized controlled study.
Patients with cataract had phacoemulsification and intraocular lens implantation in 1 eye. They were randomly assigned to receive OVD 1 or OVD 2. Preoperative and postoperative examinations over 3 months included mean intraocular pressure (IOP), incidence of IOP peaks (≥30 mm Hg and ≥24 mm Hg), endothelial cell count (ECC), corneal thickness, and intraocular inflammation. A subjective evaluation of the OVDs was performed.
The study comprised 220 patients. The incidence of IOP peaks and the mean IOP were not statistically significantly different between the 2 groups at any of the follow-up visits. At 6 hours, the incidence of IOP spikes 30 mm Hg or higher was 6.5% and 7.2% in the OVD 1 and the OVD 2 groups, respectively (P = .846). For the IOP spikes 24 mm Hg or higher, the incidence was 16.8% and 25.2%, respectively (P = .128). Three months postoperatively there was no statistically significant difference in ECC and pachymetry between the 2 groups. Mild inflammation was noticed up to 7 days postoperatively after which it resolved in both groups. Subjectively, the OVD 2 was easier to use, whereas the OVD 1 had better cohesive and dispersive properties.
Both OVDs have similar performance and safety profiles in phacoemulsification cataract surgery. No clinically relevant differences were found between the 2 devices regarding transient IOP spikes, mean IOP, corneal endothelium injury, or inflammation.
比较两种眼科粘弹剂（OVD）——双粘弹剂（OVD 1）和 DuoVisc（OVD 2）在白内障手术中的临床性能和安全性。
欧洲多中心研究。
前瞻性随机对照研究。
患有白内障的患者一只眼睛接受超声乳化白内障吸除术和人工晶状体植入术。他们被随机分配接受 OVD 1 或 OVD 2。3 个月的术前和术后检查包括平均眼压（IOP）、眼压峰值（≥30 mmHg 和≥24 mmHg）的发生率、内皮细胞计数（ECC）、角膜厚度和眼内炎症。对 OVD 进行了主观评估。
该研究包括 220 名患者。在任何一次随访中，两组之间眼压峰值的发生率和平均眼压在统计学上均无显著差异。在 6 小时时，OVD 1 组和 OVD 2 组眼压达到 30 mmHg 或更高的尖峰发生率分别为 6.5%和 7.2%（P = 0.846）。对于眼压达到 24 mmHg 或更高的尖峰，发生率分别为 16.8%和 25.2%（P = 0.128）。术后 3 个月，两组之间的 ECC 和角膜测厚在统计学上无显著差异。术后 7 天内均观察到轻度炎症，之后两组炎症均消退。主观上，OVD 2 更易于使用，而 OVD 1 具有更好的内聚性和分散性。
两种 OVD 在超声乳化白内障手术中具有相似的性能和安全性。在短暂眼压尖峰、平均眼压、角膜内皮损伤或炎症方面，两种器械之间未发现临床相关差异。
