PURPOSE: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Sensar OptiEdge AR40e intraocular lens (IOL) with that of the double-round edge design of the Sensar AR40 IOL over a period of 3 years. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS:Fifty-three patients with bilateral age-related cataract (106 eyes) were included in this randomized prospective bilateral patient- and examiner-masked clinical trial with intraindividual comparison. Each study patient had cataract surgery in both eyes and received a Sensar AR40 IOL (anterior and posterior round optic edges) in 1 eye and a Sensar OptiEdge AR40e IOL (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at 1 week, 1 and 6 months, and 1, 2, and 3 years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slitlamp and objectively using automated image-analysis software (AQUA) 1, 2, and 3 years after surgery. RESULTS: The sharp-edged AR40e lens showed significantly less regeneratory and fibrotic PCO 1, 2, and 3 years after surgery. The mean AQUA PCO score was 2.18 for the AR40 and 1.00 for the AR40e lens after 1 year; 2.94 and 1.56 after 2 years, and estimated at 3.13 and 1.77, respectively, after 3 years (scale 0 to 10; P<.001). The neodymium:YAG laser capsulotomy rate was significantly higher in the AR40 group. The AR40e lens also led to less peripheral fibrotic PCO. There was no significant difference in complaints concerning edge glare between the groups. CONCLUSION: Compared with the AR40 IOL, the sharp posterior optic edge design of the Sensar OptiEdge AR40e IOL led to significantly less PCO 1, 2, and 3 years postoperatively. In contrast with most past studies on PCO-preventative factors, this study varied only 1 parameter, namely the optic edge design, and the main outcome measure (PCO) was assessed with an objective image-analysis system.
RCT Entities:
PURPOSE: To compare the posterior capsule opacification (PCO) inhibiting effect of the sharp posterior optic edge design of the Sensar OptiEdge AR40e intraocular lens (IOL) with that of the double-round edge design of the Sensar AR40 IOL over a period of 3 years. SETTING: Department of Ophthalmology, Medical University of Vienna, Vienna, Austria. METHODS: Fifty-three patients with bilateral age-related cataract (106 eyes) were included in this randomized prospective bilateral patient- and examiner-masked clinical trial with intraindividual comparison. Each study patient had cataract surgery in both eyes and received a Sensar AR40 IOL (anterior and posterior round optic edges) in 1 eye and a Sensar OptiEdge AR40e IOL (round anterior and sharp posterior optic edge) in the other eye. Follow-up examinations were at 1 week, 1 and 6 months, and 1, 2, and 3 years. Digital retroillumination images were taken of each eye. The amount of PCO was assessed subjectively at the slitlamp and objectively using automated image-analysis software (AQUA) 1, 2, and 3 years after surgery. RESULTS: The sharp-edged AR40e lens showed significantly less regeneratory and fibrotic PCO 1, 2, and 3 years after surgery. The mean AQUA PCO score was 2.18 for the AR40 and 1.00 for the AR40e lens after 1 year; 2.94 and 1.56 after 2 years, and estimated at 3.13 and 1.77, respectively, after 3 years (scale 0 to 10; P<.001). The neodymium:YAG laser capsulotomy rate was significantly higher in the AR40 group. The AR40e lens also led to less peripheral fibrotic PCO. There was no significant difference in complaints concerning edge glare between the groups. CONCLUSION: Compared with the AR40 IOL, the sharp posterior optic edge design of the Sensar OptiEdge AR40e IOL led to significantly less PCO 1, 2, and 3 years postoperatively. In contrast with most past studies on PCO-preventative factors, this study varied only 1 parameter, namely the optic edge design, and the main outcome measure (PCO) was assessed with an objective image-analysis system.