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Safety and Performance of a New Cohesive Ophthalmic Viscosurgical Device - a Multicenter, Partially Comparative
Carmen Vogt1, Maria Xeroudaki2, Alexander Fridberg3
1Bohus Biotech, Strömstad, Sweden.
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.
