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

J Cataract Refract Surg. 2017 Jan;43(1):87-94. doi: 10.1016/j.jcrs.2016.10.025.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anterior Chamber / drug effects
  • Cell Count
  • Chondroitin Sulfates / administration & dosage*
  • Chondroitin Sulfates / adverse effects
  • Corneal Pachymetry
  • Drug Combinations
  • Endothelium, Corneal / cytology
  • Female
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects
  • Intraocular Pressure / physiology
  • Lens Implantation, Intraocular*
  • Male
  • Middle Aged
  • Phacoemulsification*
  • Prospective Studies
  • Tonometry, Ocular
  • Viscosupplements / administration & dosage*
  • Viscosupplements / adverse effects

Substances

  • Drug Combinations
  • Viscosupplements
  • Hyaluronic Acid
  • Chondroitin Sulfates