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

Purpose: 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.

Setting: United States multicenter study.

Design: Prospective, randomized, masked, controlled study.

Methods: 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 3 months 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 (≥30 mm Hg) was calculated. Changes from baseline in IOP, edema, inflammation, serious adverse events, and visual acuity were also assessed.

Results: The study comprised 213 and 208 treated and paired-eye patients, respectively. At 3 months, 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 3 months, both OVD groups had significant reductions in IOP from baseline (-1.37 mm Hg and -1.32 mm Hg, respectively; both P < .0001). The distribution of edema, inflammation, serious adverse events, and visual acuity outcomes was also similar between the groups.

Conclusion: The 2 OVDs were clinically similar in terms of safety and effectiveness for cataract surgery.