Comparison of Safety and Efficacy of Two Dispersive Hyaluronate OVDs Used in Cataract Surgery.

PURPOSE: To compare safety and efficacy of ophthalmic viscosurgical devices (OVDs) - OphteisBio 3.0 (Rayner) and Healon Endocoat (J&J Vision) in phacoemulsification cataract removal surgery. MATERIALS AND METHODS: In this prospective subject/evaluator-masked post-market randomized study patients undergoing phacoemulsification were assigned to receive one of two hyaluronate-based OVDs - OphteisBio 3.0 and Healon Endocoat. The outcomes were the rate of intraocular pressure (IOP) spikes ≥ 30 mmHg at the 7-day postoperative visit, endothelial cell density changes, the surgeon acceptance rate, IOP change from baseline, rates of inflammation and rates of serious and/or device-related adverse events. RESULTS: The study included 293 eyes - 146 in the Ophteis group and 147 in the Healon group. No IOP spikes were noted at the 7-day postoperative visit with mean IOP of 14.5 mmHg for Ophteis group and 14.3 mmHg for the Healon group. The mean endothelial cell density loss after the surgery was 9.8% in the Ophteis group and 10.2% in the Healon group with no statistically significant difference between the two OVD groups (p = 0.6292). At the 7-day visit, anterior chamber flare was absent in 98% and 99% of eyes in the Ophteis and Healon group, respectively. 82% of eyes had no anterior chamber cells at 7-day visit in both groups. No adverse events were recorded during surgery and at 7-day follow up. No clinically relevant differences were found between the two OVDs. CONCLUSION: Ophteis 3.0 and Healon Endocoat have comparable results following phacoemulsification surgery.