PURPOSE: To verify the safety and effectiveness of the new AcrySof Natural (Alcon Laboratories, Inc.) blue-light filtering intraocular lens (IOL), which was designed to achieve a light-transmission spectrum similar to that of the natural human crystalline lens. SETTING: Multicenter U.S. clinical trial. METHODS: In a prospective randomized patient-masked multicenter study, 150 patients received theAcrySof Natural IOLand 147 patients received theAcrySof single-piece IOL as a control. Patients with bilateral age-related cataracts who were willing and able to wait at least 30 days between cataract procedures and had verified normal preoperative color vision were eligible for the study. Standardized surgery included a 4.0 to 5.0 mm capsulorhexis and phacoemulsification. All lenses were inserted in the capsular bag, with verification of in-the-bag placement of both haptics. In all bilateral implantation cases, the same model IOL was used in each eye. Postoperatively, contrast sensitivity and color perception were measured up to 180 days and up to 1 year (for visual acuity) after implantation. RESULTS: No statistically significant differences were discovered between the 2 patient groups in visual acuity, contrast sensitivity evaluated under mesopic and photopic conditions, or the number of patients who passed the Farnsworth D-15 color perception test. There were no lens-related adverse events in either group. CONCLUSIONS: The blue-light filtering AcrySof Natural IOL was equivalent to the conventional AcrySof lens in terms of postoperative visual performance. Additional long-term clinical studies should show whether the IOL actually provides the theoretical benefits to retinal health.
RCT Entities:
PURPOSE: To verify the safety and effectiveness of the new AcrySof Natural (Alcon Laboratories, Inc.) blue-light filtering intraocular lens (IOL), which was designed to achieve a light-transmission spectrum similar to that of the natural human crystalline lens. SETTING: Multicenter U.S. clinical trial. METHODS: In a prospective randomized patient-masked multicenter study, 150 patients received the AcrySof Natural IOL and 147 patients received the AcrySof single-piece IOL as a control. Patients with bilateral age-related cataracts who were willing and able to wait at least 30 days between cataract procedures and had verified normal preoperative color vision were eligible for the study. Standardized surgery included a 4.0 to 5.0 mm capsulorhexis and phacoemulsification. All lenses were inserted in the capsular bag, with verification of in-the-bag placement of both haptics. In all bilateral implantation cases, the same model IOL was used in each eye. Postoperatively, contrast sensitivity and color perception were measured up to 180 days and up to 1 year (for visual acuity) after implantation. RESULTS: No statistically significant differences were discovered between the 2 patient groups in visual acuity, contrast sensitivity evaluated under mesopic and photopic conditions, or the number of patients who passed the Farnsworth D-15 color perception test. There were no lens-related adverse events in either group. CONCLUSIONS: The blue-light filtering AcrySof Natural IOL was equivalent to the conventional AcrySof lens in terms of postoperative visual performance. Additional long-term clinical studies should show whether the IOL actually provides the theoretical benefits to retinal health.
Authors: Vivienne C Greenstein; Flavia Chiosi; Paul Baker; William Seiple; Karen Holopigian; Richard E Braunstein; Janet R Sparrow Journal: J Cataract Refract Surg Date: 2007-04 Impact factor: 3.351
Authors: James A Davison; Anil S Patel; Joao P Cunha; Jim Schwiegerling; Orkun Muftuoglu Journal: Graefes Arch Clin Exp Ophthalmol Date: 2011-05-17 Impact factor: 3.117
Authors: M Amparo DIez-Ajenjo; M Carmen GarcIa-Domene; Cristina Peris-MartInez; Jos M Artigas; Adelina Felipe Journal: Indian J Ophthalmol Date: 2014-11 Impact factor: 1.848