Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery.

J Cataract Refract Surg

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.

Published: January 2017

Purpose: To compare the clinical performance and safety of 2 ophthalmic viscosurgical devices (OVDs)-Twinvisc (OVD 1) and Duovisc (OVD 2)-in cataract surgery.

Setting: European multicenter study.

Design: Prospective randomized controlled study.

Methods: 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.

Results: 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.

Conclusions: 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.

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http://dx.doi.org/10.1016/j.jcrs.2016.10.025DOI Listing

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