Acrysof sn60at and ma60ac iols

The study design, surgical technique, follow-up schedules, optical correction and patching regimens, and examination methods have been reported in detail previously .^{12 (link)} The main inclusion criteria were a visually significant congenital cataract (≥ 3 mm central opacity) in one eye, a normal fellow eye and an age of 28 days to <210 days at the time of cataract surgery. Infants were randomly assigned to either contact lens (CL) treatment or implantation of an IOL and spectacle overcorrection. Randomization was centrally determined using stratification between two age groups (28-48 days and 49-210 days) as well as study centers, which were grouped into 3 categories based on experience of the surgeon.
The study followed the tenets of the Declaration of Helsinki, was approved by the institutional review boards of the participating institutions and was in compliance with the Health Insurance Portability and Accountability Act. The off-label research use of the Acrysof SN60AT and MA60AC IOLs (Alcon Laboratories, Fort Worth, Texas) was covered by US Food and Drug Administration investigational device exemption # G020021.

The study design (multi-center randomized clinical trial), surgical techniques, follow up schedule and patient characteristics at baseline, as well as the clinical findings at one year of age have been reported in detail previously and are only summarized here. (4 (link), 19 (link)) This study was approved by the Institutional Review Boards of all 12 participating institutions and was in compliance with the Health Insurance Portability and Accountability Act. Informed consent was obtained from all parents or guardians. The off-label research use of the Acrysof SN60AT and MA60AC IOLs (Alcon Laboratories, Fort Worth, Texas) was covered by US Food and Drug Administration investigational device exemption # G020021. The trial is registered at www.clincaltrials.gov (Identifier- NCT00212134).