Clinical assessment of long-term safety and efficacy of a widely implantedpolyacrylic intraocular lens material

PURPOSE: To evaluate the long-term safety and efficacy, in a large series o f patients, of polyacrylic intraocular lens implants 1 and 3 years after su rgery, compared with polymethylmethacrylate intraocular lens implants. METHODS: This was a randomized, prospective study of 1,514 eyes of 1,202 pa tients that were examined for a 1-year follow-up study and 1,264 eyes of 99 0 patients that were examined for a 3 year follow-up study. All the patient s were prospectively randomized to receive a polyacrylic or polymethylmetha crylate intraocular lens implant. A standardized surgical protocol was perf ormed using a phacoemulsification technique and capsulorhexis. Any surgical complications were excluded, and all patients had standard postoperative m edication and follow-up. Postoperative measurements included spectacle-corr ected visual acuity, occurrence of postoperative sight-threatening or lens- related complications, and adverse reactions. Results: were compared between the polyacrylic intraocular lens and polymet hylmethacrylate intraocular lens groups. Results were also compared with st andards for polymethylmethacrylate intraocular lens that were established b y the US Food and Drug Administration and a previous study for silicone len s. RESULTS: The overall complete follow-up rates were 79.9% for 1-year foll ow-up and 69.5% for 3-year follow up. At 1 year, the mean logarithm of the minimum angle of resolution (logMAR) of visual acuity was 0.037 +/- 0.150 a nd 0.042 +/- 0.154 in best case patients of the polyacrylic intraocular len s group and polymethylmethacrylate intraocular lens group, respectively. At 3 years, the mean logMAR visual acuity was 0.038 +/- 0.155 and 0.054 +/- 0 .181 in best case patients in the polyacrylic intraocular lens group and po lymethylmethacrylate intraocular lens group. There was no significant diffe rence between groups at 1 and 3 years. At 1 year, 96.8% of best case patien ts in the polyacrylic intraocular lens group and 95.8% of those in the poly methylmethacrylate intraocular lens group achieved corrected Visual acuity of 0.5 or better. At 3 years, 96.4% of best case patients in the polyacryli c intraocular lens group and 94.9% of those in the polymethylmethacrylate g roup achieved a corrected visual acuity of 0.5 or better; no significant di fference was found at 1 and 3 years. The rate of sight-threatening complica tions was 1.2% for the polyacrylic intraocular lens group of all patients a nd 1.5% for the polymethylmethacrylate intraocular lens group at 1 year, an d 1.6% for the polyacrylic intraocular lens group and 1.4% for the polymeth ylmethacrylate intraocular lens group at 3 years. No significant difference was found between the groups. The cumulative rate of Nd:YAG capsulotomy fo r the polyacrylic intraocular lens group (7.1%) was significantly lower tha n that for the polymethylmethacrylate intraocular lens group (38.1%) throug h 3 years (P <.0001). CONCLUSIONS: Polyacrylic intraocular lenses demonstrated safe and effective performance through long-term follow-up at a level equal to or better than polymethylmethacrylate intraocular lenses. Patients undergoing polyacrylic intraocular Lens implantation achieved excellent postoperative visual acui ty and experienced a low rate of postoperative complications, adverse react ions, and Nd:YAG capsulotomy. These long-term clinical results are an impor tant outcome database for the ongoing use of this foldable optic material. (C) 2000 by Elsevier Science Inc. All rights reserved.