Clinical evaluation of a bacterially derived sodium hyaluronate 2.3% ophthalmic viscosurgical device

Abstract

To compare the safety and effectiveness of bacterially derived and animal-derived sodium hyaluronate 2.3% ophthalmic viscosurgical devices (OVD) (Healon5 PRO and Healon5, respectively) in cataract surgery. United States multicenter study. Prospective, randomized, masked, controlled study. Adult patients having bilateral cataract extraction and posterior chamber intraocular lens implantation were randomly assigned to receive Healon5 PRO OVD in 1 eye (study group) and Healon5 OVD in the fellow eye (control group). The endothelial cell count (ECC) was measured preoperatively and 3months postoperatively. Tonometry was performed preoperatively and at the 6-hour, 1-day, 1-week, 1-month, and 3-month timepoints. The cumulative rate of postoperative intraocular pressure (IOP) spikes (≥30mm Hg) was calculated. Changes from baseline in IOP, edema, inflammation, serious adverse events, and visual acuity were also assessed. The study comprised 213 and 208 treated and paired-eye patients, respectively. At 3months, there was no statistically significant difference in the mean percentage ECC change from baseline between study group and the control group (-5.55% versus -6.66%; mean difference 1.11%±11.89% [SD]; 95% confidence interval (CI), -0.52 to 2.74) or the cumulative IOP spike rate (8.2% versus 6.3%; mean percentage difference -1.9%; 95% CI, -5.46% to 1.61%). At 3months, both OVD groups had significant reductions in IOP from baseline (-1.37mm Hg and -1.32mm Hg, respectively; both P<.0001). The distribution of edema, inflammation, serious adverse events, and visual acuity outcomes was also similar between the groups. The 2 OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.