PURPOSE: To compare the overall clinical performance during phacoemulsification and intraocular lens (IOL) implantation, the effect on intraocular pressure (IOP), and the effect on corneal endothelium of Healon5 (sodium hyaluronate 2.3%) and Healon (sodium hyaluronate 1.0%) ophthalmic viscosurgical devices (OVDs). SETTING: Multicenter study. METHODS: In this randomized prospective clinical study, the performance of Healon5 (viscoadaptive; dispersive and cohesive) and Healon (cohesive) during cataract surgery was evaluated in 157 patients, 79 with Healon5 and 78 with Healon. Surgeons evaluated the following on a 5-point scale: retention during phacoemulsification (primary endpoint), ease of injection, anterior chamber maintenance during continuous curvilinear capsulorhexis (CCC), facilitation of IOL implantation, and ease of removal from the eye. Masked examiners other than the surgeon performed the following measurements: IOP preoperatively and 5 and 24 hours, 7 days, and 3 months postoperatively; corneal thickness before and 24 hours, 7 days, and 3 months postoperatively; and corneal endothelial cell count preoperatively and 3 months postoperatively. RESULTS:Intraocular retention during phacoemulsification was assessed as good or very good in 77% in the Healon5 group and 8% in the Healon group; the difference was statistically significant (P<.0001, Wilcoxon rank sum test). The Healon5 group had significantly better scores for anterior chamber maintenance during CCC (P<.0001) and facilitation of IOL implantation (P =.032), and the Healon group had significantly better scores for ease of injection (P<.0001) and ease of removal (P<.0001). There were no statistically significant between-group differences in IOP, corneal endothelial cell count, or corneal thickness. CONCLUSIONS: Surgeons rated Healon5 better than Healon in retention during phacoemulsification, anterior chamber maintenance during CCC, and facilitation of IOL implantation. They assessed Healon as easier to inject and remove. There was no difference in safety-related parameters between the 2 OVDs. These findings indicate that Healon5 is effective in cataract surgery.
RCT Entities:
PURPOSE: To compare the overall clinical performance during phacoemulsification and intraocular lens (IOL) implantation, the effect on intraocular pressure (IOP), and the effect on corneal endothelium of Healon5 (sodium hyaluronate 2.3%) and Healon (sodium hyaluronate 1.0%) ophthalmic viscosurgical devices (OVDs). SETTING: Multicenter study. METHODS: In this randomized prospective clinical study, the performance of Healon5 (viscoadaptive; dispersive and cohesive) and Healon (cohesive) during cataract surgery was evaluated in 157 patients, 79 with Healon5 and 78 with Healon. Surgeons evaluated the following on a 5-point scale: retention during phacoemulsification (primary endpoint), ease of injection, anterior chamber maintenance during continuous curvilinear capsulorhexis (CCC), facilitation of IOL implantation, and ease of removal from the eye. Masked examiners other than the surgeon performed the following measurements: IOP preoperatively and 5 and 24 hours, 7 days, and 3 months postoperatively; corneal thickness before and 24 hours, 7 days, and 3 months postoperatively; and corneal endothelial cell count preoperatively and 3 months postoperatively. RESULTS: Intraocular retention during phacoemulsification was assessed as good or very good in 77% in the Healon5 group and 8% in the Healon group; the difference was statistically significant (P<.0001, Wilcoxon rank sum test). The Healon5 group had significantly better scores for anterior chamber maintenance during CCC (P<.0001) and facilitation of IOL implantation (P =.032), and the Healon group had significantly better scores for ease of injection (P<.0001) and ease of removal (P<.0001). There were no statistically significant between-group differences in IOP, corneal endothelial cell count, or corneal thickness. CONCLUSIONS: Surgeons rated Healon5 better than Healon in retention during phacoemulsification, anterior chamber maintenance during CCC, and facilitation of IOL implantation. They assessed Healon as easier to inject and remove. There was no difference in safety-related parameters between the 2 OVDs. These findings indicate that Healon5 is effective in cataract surgery.