There is a need for a synthetic, clear visoelastic fluid for use in ophthalmic surgery which is lower in cost, more convenient to use and comparable in surgical performance o sodium hyaluronate MDR Group, Inc. is developing an ophthalmic viscoelastic fluid system which is used both topically on the eye during surgery and intraocularly in the conventional fashion. The intraocular fluid may minimize corneal swelling and intraocular pressure rises post-operatively. The topical fluid will provide superior corneal moisturization and surgeon visualization during surgery, delaying the drying effects of the intense heat from the operating microscope light. The topical fluid may need only be applied every eight to ten minutes during surgery compared to the interval of 30 second applications with balanced salt solution, the only topical solution now used. The topical and intraocular solutions are expected to work together to provide superior corneal epithelial and endothelial cell protection during surgery. The objective of phase I is to complete the development of the product system and qualify it for human clinical trials under a U.S. FDA Investigational Device Exemption. The potential for innovation exists in developing viscoelastics with """"""""tailored"""""""" rheologic properties for specific surgical applications from low cost readily available synthetic materials.
