‘Comparison of Safety and Performance of Two Ophthalmic Viscosurgical Devices in Cataract Surgery’

Abstract

\n Purpose: To compare the safety and performance of two ophthalmic viscosurgical devices (OVDs) Bio-Hyalur SV (Sodium Hyaluronate 3.0%) (Biotech Healthcare Group, Luzern, Switzerland) and Protectalon (sodium hyaluronate 2.0%) (VSY Biotechnology, Turkey) in cataract surgery. Methods: One hundred twenty eyes of one hundred twenty patients who underwent phacoemulsification surgery were included in the study. Postoperatively sixty eyes using Bio-Hyalur-SV were classified as Group 1, and sixty eyes using Protectalon as Group 2. Patients aged 45 and over, Grade I, II or III unilateral / double stained cataract, healthy eyes creating cataract inclueded in this study . Endothelial cell morphological parameters including endothelial cell density (ECD), cell number, cell area, coefficient of variation (CV) in cell size, cell hexagonality and central corneal thickness (CCT) were measured preoperatively and at postoperative first week, first and third month visits.Intraocular pressure (IOP) was measured with an applanation tonometer at every visit. Results: . There was a statistically significant decrease in the mean ECD all follow-up times when compared with the preoperative visit (p=0.000). In terms of mean ECD levels there was no significant difference between the two groups within three months postoperatively (p=0.616) In the first week after surgery, there was an significant increase in CCT in Group 1 and Group 2 respectively (p=0.000). The IOP was <23 mmHg in all of the patients on the first day after surgery. There was no significant difference in the incidence of IOP peaks between the two groups in every vizits. In both groups, a significant increase was observed in the mean IOP at first day, first week, and first month after surgery compared to preoperative values (p=0.000). But no significant difference in IOP increase in Group 1 (P=0.092), Group 2 (P=0.013) compared to preoperative values \u200b\u200bat third month postoperatively (p <0.001 significant with Bonferrotti correction). Conclusion: The two OVD’s used in this study during cataract surgery were safe and effective. Both OVD’s resulted in similar rates of transient IOP increases and corneal endothelial damage also provided good anterior chamber depth and were fairly easy to remove.