Multicenter trial of an intraocular hydrogel lens implant

Abstract

Several features suggest that hydrogels may have potential advantages as an intraocular lens material. The IOGEL lens is a single piece hydrogel composed of 38% poly HEMA. Clinical experience with the IOGEL lens in Australia has been published, and the safety and efficacy of the lens is currently being investigated in a multicenter trial in Europe, the U.S.A., Canada, Australia, and Japan. This is the first large-scale study of a hydrogel implant. The IOGEL lens clinical study was initiated in May 1986 in Europe, in September 1986 in the U.S.A., and in November 1986 in Canada and Australia. The enrollment progress in May 1987 showed that 501 cases had been implanted in Europe, Canada, and Australia and 100 cases in the U.S.A. The visual acuity outcome is equivalent to that reported in the literature. Patients in the multinational trial achieved 20/40 or better in 86% of cases and in 96% of cases excluding unrelated pathologies. Although hydrogels have only had limited use in the clinical situation, the results of this study suggest that the IOGEL lens is a viable alternative to polymethylmethacrylate lens implants.