Clinical trial evaluating Viscoat and Visthesia ophthalmic viscosurgical devices in corneal endothelial loss after cataract extraction and intraocular lens implantation.

ABSTRACT

PURPOSE: To assess and compare the safety and the efficacy of VisThesia™ and Viscoat® in cataract surgery. METHODS: This prospective randomized clinical trial included 44 eyes of 44 patients that were assigned randomly to undergo phacoemulsification either with VisThesia™ or with Viscoat®. Preoperative data included age, gender, visual acuity, IOP and mean endothelial cell density. Postoperative, best corrected visual acuity (BCVA), IOP, mean endothelial cell density and painful sensation during surgery were recorded. RESULTS: BCVA, evaluated with Snellen chart in decimal fraction, was statistically improved in both groups. Specifically, mean BCVA in VisThesia group was increased from 0.28 ± 1.8 SD preoperatively to 0.83 ± 1.4 SD postoperatively, whereas, in the Viscoat group, BCVA was increased from 0.31 ± 2.1 SD preoperatively, to 0.85 ± 1.2 SD after surgery (p > 0.1). The mean postoperative IOP was lower in the VisThesia group, but the difference was not statistically significant (p > 0.1). Preoperatively, the mean endothelial cell count was 2322.3 ± 161.1 SD cells/mm(2) in Viscoat group and 2304.8 ± 142.8 SD cells/mm(2) in the VisThesia group, similar between groups (p > 0.1). At day 15 after cataract surgery the postoperative endothelial cell count was 2102.9 ± 182.8 SD cells/mm(2) in Viscoat group and 2032.6 ± 160.4 SD cells/mm(2) in the VisThesia group (p > 0.1). The mean endothelial cell decrease was 212 cells/mm(2) (9.1%) in the Viscoat group and 272 cells/mm(2) (11.8%) in the VisThesia group. The difference was not statistically significant between the two groups (t-test = 0.18, p > 0.1). This value is within standard normal endothelial cell decrease after a cataract surgery. Painful sensation was not reported during any stage of the procedure. CONCLUSIONS: Topical-intracameral anesthesia with VisThesia™ allows cataract surgery without any painful sensation in the majority of patients. Both Viscoat® and VisThesia™ have similar safety profile during intra- and post-operative period and identical endothelial protection, as endothelial cell loss is within normal limits.