Randomized clinical comparison of Healon GV and Viscoat 1
Kevin M. Miller, Michael D. Colvard
Abstract
Kevin M. Miller, Michael D. Colvard
Abstract
PURPOSE: To compare the ability of Healon GV (sodium hyaluronate 1.4%) and Viscoat (sodium chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) to protect the corneal endothelium during endocapsular phacoemulsification and foldable intraocular lens (IOL) implantation. SETTING: A small ophthalmology group practice. METHODS: One hundred forty patients were randomized, 70 per group, in a prospective, partially masked study of cataract surgery using Healon GV or Viscoat. One ophthalmologist performed all surgery. Primary outcome variables were the 2 week postoperative changes in corneal thickness, endothelial cell density, mean endothelial cell size, and endothelial cell hexagonality. Several secondary variables were measured, and an analysis of the statistical power of the study was performed. RESULTS: There were no statistically significant differences between groups in terms of age (P = .856), cataract density (P = .117), preoperative best corrected visual acuity (BCVA) (P = .892), postoperative BCVA (P = .969), amount of viscoelastic material used during surgery (P = .444), amount of irrigating solution used (P = .125), or phacoemulsification time (P = .088). It took longer to remove the Viscoat than the Healon GV (P < .001), and total operating time for the Viscoat group was longer (P < .001). Two weeks after surgery, there were no significant differences between groups in corneal thickness (P = .362), endothelial cell density (P = .351), or mean endothelial cell size (P = .610). However, Viscoat preserved the hexagonal shape of endothelial cells slightly better than Healon GV (P = .043). The study had sufficient power to detect clinically significant differences in corneal thickness, endothelial cell density, and endothelial cell size. CONCLUSIONS: Healon GV and Viscoat were comparable in their ability to protect the corneal endothelium during endocapsular phacoemulsification and foldable IOL implantation. Results may vary, however, if phacoemulsification is performed anterior to the iris plane.
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PURPOSE: To compare the ability of Healon GV (sodium hyaluronate 1.4%) and Viscoat (sodium chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) to protect the corneal endothelium during endocapsular phacoemulsification and foldable intraocular lens (IOL) implantation. SETTING: A small ophthalmology group practice. METHODS: One hundred forty patients were randomized, 70 per group, in a prospective, partially masked study of cataract surgery using Healon GV or Viscoat. One ophthalmologist performed all surgery. Primary outcome variables were the 2 week postoperative changes in corneal thickness, endothelial cell density, mean endothelial cell size, and endothelial cell hexagonality. Several secondary variables were measured, and an analysis of the statistical power of the study was performed. RESULTS: There were no statistically significant differences between groups in terms of age (P = .856), cataract density (P = .117), preoperative best corrected visual acuity (BCVA) (P = .892), postoperative BCVA (P = .969), amount of viscoelastic material used during surgery (P = .444), amount of irrigating solution used (P = .125), or phacoemulsification time (P = .088). It took longer to remove the Viscoat than the Healon GV (P < .001), and total operating time for the Viscoat group was longer (P < .001). Two weeks after surgery, there were no significant differences between groups in corneal thickness (P = .362), endothelial cell density (P = .351), or mean endothelial cell size (P = .610). However, Viscoat preserved the hexagonal shape of endothelial cells slightly better than Healon GV (P = .043). The study had sufficient power to detect clinically significant differences in corneal thickness, endothelial cell density, and endothelial cell size. CONCLUSIONS: Healon GV and Viscoat were comparable in their ability to protect the corneal endothelium during endocapsular phacoemulsification and foldable IOL implantation. Results may vary, however, if phacoemulsification is performed anterior to the iris plane.
Key concepts: Phacoemulsification, Sodium hyaluronate, Corneal endothelium, Ophthalmology, Medicine, Intraocular lens, Cataract surgery, Cornea