PURPOSE: To evaluate the long-term safety and efficacy, in a large series of patients, of polyacrylic intraocular lens implants 1 and 3 years after surgery, compared with polymethylmethacrylate intraocular lens implants. METHODS: This was a randomized, prospective study of 1,514 eyes of 1,202 patients that were examined for a 1-year follow-up study and 1,264 eyes of 990 patients that were examined for a 3-year follow-up study. All the patients were prospectively randomized to receive a polyacrylic or polymethylmethacrylate intraocular lens implant. A standardized surgical protocol was performed using a phacoemulsification technique and capsulorhexis. Any surgical complications were excluded, and all patients had standard postoperative medication and follow-up. Postoperative measurements included spectacle-corrected visual acuity, occurrence of postoperative sight-threatening or lens-related complications, and adverse reactions. Results were compared between the polyacrylic intraocular lens and polymethylmethacrylate intraocular lens groups. Results were also compared with standards for polymethylmethacrylate intraocular lens that were established by the US Food and Drug Administration and a previous study for silicone lens. RESULTS: The overall complete follow-up rates were 79.9% for 1-year follow-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 and 0.042 +/- 0.154 in best case patients of the polyacrylic intraocular lens 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 polymethylmethacrylate intraocular lens group. There was no significant difference between groups at 1 and 3 years. At 1 year, 96.8% of best case patients in the polyacrylic intraocular lens group and 95.8% of those in the polymethylmethacrylate intraocular lens group achieved corrected visual acuity of 0.5 or better. At 3 years, 96.4% of best case patients in the polyacrylic intraocular lens group and 94.9% of those in the polymethylmethacrylate group achieved a corrected visual acuity of 0.5 or better; no significant difference was found at 1 and 3 years. The rate of sight-threatening complications was 1. 2% for the polyacrylic intraocular lens group of all patients and 1. 5% for the polymethylmethacrylate intraocular lens group at 1 year, and 1.6% for the polyacrylic intraocular lens group and 1.4% for the polymethylmethacrylate intraocular lens group at 3 years. No significant difference was found between the groups. The cumulative rate of Nd:YAG capsulotomy for the polyacrylic intraocular lens group (7.1%) was significantly lower than that for the polymethylmethacrylate intraocular lens group (38.1%) through 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 acuity and experienced a low rate of postoperative complications, adverse reactions, and Nd:YAG capsulotomy. These long-term clinical results are an important outcome database for the ongoing use of this foldable optic material.
RCT Entities:
PURPOSE: To evaluate the long-term safety and efficacy, in a large series of patients, of polyacrylic intraocular lens implants 1 and 3 years after surgery, compared with polymethylmethacrylate intraocular lens implants. METHODS: This was a randomized, prospective study of 1,514 eyes of 1,202 patients that were examined for a 1-year follow-up study and 1,264 eyes of 990 patients that were examined for a 3-year follow-up study. All the patients were prospectively randomized to receive a polyacrylic or polymethylmethacrylate intraocular lens implant. A standardized surgical protocol was performed using a phacoemulsification technique and capsulorhexis. Any surgical complications were excluded, and all patients had standard postoperative medication and follow-up. Postoperative measurements included spectacle-corrected visual acuity, occurrence of postoperative sight-threatening or lens-related complications, and adverse reactions. Results were compared between the polyacrylic intraocular lens and polymethylmethacrylate intraocular lens groups. Results were also compared with standards for polymethylmethacrylate intraocular lens that were established by the US Food and Drug Administration and a previous study for silicone lens. RESULTS: The overall complete follow-up rates were 79.9% for 1-year follow-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 and 0.042 +/- 0.154 in best case patients of the polyacrylic intraocular lens 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 polymethylmethacrylate intraocular lens group. There was no significant difference between groups at 1 and 3 years. At 1 year, 96.8% of best case patients in the polyacrylic intraocular lens group and 95.8% of those in the polymethylmethacrylate intraocular lens group achieved corrected visual acuity of 0.5 or better. At 3 years, 96.4% of best case patients in the polyacrylic intraocular lens group and 94.9% of those in the polymethylmethacrylate group achieved a corrected visual acuity of 0.5 or better; no significant difference was found at 1 and 3 years. The rate of sight-threatening complications was 1. 2% for the polyacrylic intraocular lens group of all patients and 1. 5% for the polymethylmethacrylate intraocular lens group at 1 year, and 1.6% for the polyacrylic intraocular lens group and 1.4% for the polymethylmethacrylate intraocular lens group at 3 years. No significant difference was found between the groups. The cumulative rate of Nd:YAG capsulotomy for the polyacrylic intraocular lens group (7.1%) was significantly lower than that for the polymethylmethacrylate intraocular lens group (38.1%) through 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 acuity and experienced a low rate of postoperative complications, adverse reactions, and Nd:YAG capsulotomy. These long-term clinical results are an important outcome database for the ongoing use of this foldable optic material.