TY - JOUR
T1 - Comparison of the performance and safety of 2 ophthalmic viscosurgical devices in cataract surgery
AU - Auffarth, Gerd U.
AU - Auerbach, Florian N.
AU - Rabsilber, Tanja
AU - Gegúndez, José A.
AU - Cuiña, Ricardo
AU - Renard, Yves
AU - Vinciguerra, Paolo
AU - Camesasca, Fabrizio
AU - Van Cauwenberge, Francoise
AU - Amzallag, Thierry
AU - Van Setten, Gysbert
AU - Holzer, Mike P.
PY - 2017/1/1
Y1 - 2017/1/1
N2 - 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.
AB - 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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U2 - 10.1016/j.jcrs.2016.10.025
DO - 10.1016/j.jcrs.2016.10.025
M3 - Article
AN - SCOPUS:85015432030
VL - 43
SP - 87
EP - 94
JO - Journal of Cataract and Refractive Surgery
JF - Journal of Cataract and Refractive Surgery
SN - 0886-3350
IS - 1
ER -