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Safety and performance of a new cohesive ophthalmic viscosurgical device: multicenter, partially comparative
Carmen Vogt1, Maria Xeroudaki, Alexander Fridberg
1From the Bohus Biotech, Strömstad, Sweden (Vogt); Clinical Department of Ophthalmology, Region Östergötland, Linköping, Sweden (Xeroudaki); Ögonläkargruppen Praktikertjänst, Stockholm, Sweden (Fridberg); Department for Biomedical and Clinical Sciences, Linköping University and Department of Ophthalmology, Region Östergötland, Linköping, Sweden (Johansson).
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 postmarket study.
Methods:
Participants requiring anterior segment ophthalmic surgery were eligible for inclusion. The study consisted of 2 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 mm Hg at 7 days after 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.
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 2 cases (both in phase B), which were glaucoma surgeries. 2 eyes (1.5%) treated with Minivisc Plus exhibited intraocular pressure (IOP) ≥30 mm Hg 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 2 OVDs.
Conclusions:
This study demonstrates the safety of Minivisc Plus regarding IOP spikes, postoperative ocular inflammation, and ECD loss, with clinical performance comparable with that of Healon GV PRO.
