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.

Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

“…We have read with great interest the article by Packer et al and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.…”

“…We would like to thank the authors for their interest in our publication and respond to each of the issues they enumerate. 1 The purpose of this multicenter, masked, randomized, prospective clinical study was to assess the safety and effectiveness of StableVisc compared with ProVisc cohesive OVD. The authors suggest that surgeons' varying degrees of familiarity with the use of cohesive OVDs could represent a confounding factor in the results.…”

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Comment on: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical deviceWe have read with great interest the article by Packer et al and would like to offer critical commentary on the use and analysis of StableVisc OVD (Bausch & Lomb, Inc.). 1 We hope that these perspectives may provide insight into areas that may require further research on the topic and improve subsequent research design.First, there is a discussion of how a surgeon's technique and preferences influence their selection of an ophthalmic viscosurgical device (OVD) and further that this selection may affect the surgery success, postoperative outcome, and patient satisfaction. Then later in the Discussion section, it is noted that the surgeons were only permitted to use a cohesive OVD.

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Reply: Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device

“…We would like to thank the authors for their interest in our publication and respond to each of the issues they enumerate. 1…”