Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

Abstract

Purpose: To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. Setting: 22 sites in the United States. Design: Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). Methods: Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. Results: 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). Conclusions: The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.