Safety and Performance of a New Cohesive Ophthalmic Viscosurgical Device - a Multicenter, Partially Comparative Randomized Study.

PURPOSE: To confirm the clinical safety and overall performance of Minivisc® Plus, a cohesive ophthalmic viscosurgical device (OVD).

SETTING

Multicenter study conducted at 6 sites in Sweden and Belgium.

DESIGN

Prospective, randomized, partially comparative, multicenter post market study.

METHODS

Subjects requiring anterior segment ophthalmic surgery were eligible for inclusion. The study consisted of two phases. In Phase A (90-day follow-up), a randomized comparison was conducted between Minivisc® Plus and Healon GV® Pro. In Phase B, eyes were treated with Minivisc® Plus and followed for 30 days. Primary endpoint was incidence of intraocular pressure (IOP) ≥30 mmHg at 7 days following operation. Secondary endpoints included postoperative inflammation, corneal endothelial cell density (ECD), surgeon-reported device performance, and the incidence of adverse events (AEs) and device deficiencies (DDs).

RESULTS

In total, 163 eyes were included in the study: 54 eyes in Phase A (25 eyes treated with Minivisc® Plus and 29 eyes treated with Healon GV® Pro) and 109 eyes in Phase B. All surgical procedures were phacoemulsification cataract surgeries, apart from two cases (both in Phase B), which were glaucoma surgeries. Two eyes (1.5%) treated with Minivisc® Plus exhibited intraocular pressure (IOP) ≥30 mmHg at postoperative day 7. Inflammation grading, ECD loss, and the incidence of AEs were comparable between the study substances throughout the 90-day follow-up period. Surgeon-reported assessments indicated comparable device performance between the two OVDs.

CONCLUSIONS

This study demonstrates the safety of Minivisc® Plus in terms of IOP spikes, postoperative ocular inflammation, ECD loss, with clinical performance comparable to that of Healon GV® PRO.