Acrysof sn60at

The Infant Aphakia Treatment Study (IATS) was supported through a cooperative agreement with the United States National Eye Institute of the National Institutes of Health and performed at 12 clinical sites. The study was approved by the institutional review boards at all participating institutions and was in compliance with the U.S. Health Insurance Portability and Accountability Act. The off-label research use of the Acrysof SN60AT and Acrysof MA60AC IOLs (Alcon Laboratories, Inc.) was covered by U.S. Food and Drug Administration investigational device exemption G020021. The primary purpose was to determine whether infants with a unilateral congenital cataract are more likely to develop better vision after cataract extraction with or without primary IOL implantation.^A

The study design, surgical technique, follow-up schedules, patching and optical correction regimens, and examination methods have been reported previously and are only summarized in this report.^{6 (link),7 (link)} The study followed the tenets of the Declaration of Helsinki and 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 clinical trial is registered in clinicaltrials.gov by Identifier NCT00212134.

The study design, surgical technique, follow-up schedules, patching and optical correction regimens, and examination methods have been reported in detail previously and are only summarized in this report.¹⁸ The study followed the tenets of the Declaration of Helsinki and 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 Infant Aphakia Treatment Study is a randomized clinical trial involving 12 sites supported by a cooperative agreement with the National Eye Institute of the National Institutes of Health. The study design, surgical techniques, patching and optical correction regimens, evaluation methods, patient characteristics at baseline, monocular visual acuity at age 4.5 years and clinical findings at age 5 years have been reported previously.^{11 (link),12 (link)} Only the elements pertinent to the current paper will be briefly described here. The study and data collection were carried out with approval from the appropriate Institutional Review Board at each site. Informed Consent for the research was obtained from the parents of the participants, and the study is in accordance with the Health Insurance Portability and Accountability regulations. The off-label research use of the Acrysof SN60AT and MA60AC Intraocular Lenses (Alcon Laboratories, Fort Worth, Texas) is covered by US Food and Drug Administration investigational device exemption G020021.

The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter, longitudinal study that evaluated the clinical outcomes of 2 treatments (contact lens [CL] vs intraocular lens [IOL]) for aphakia after early surgery for unilateral infantile cataract.^{14 (link)} The randomization was stratified according to the category of the age of the infant at surgery (28–48 vs 49–210 days). The primary outcomes at 5 years of age, including visual acuity, adverse events, and strabismus have been previously described.^{13 (link)–15 (link),16 (link)} The IATS was approved by the institutional review boards of all the participating institutions and complied with the US Health Insurance Portability and Accountability Act of 1996. The off-label research use of the AcrySof SN60AT and MA60AC IOLs (Alcon Laboratories, Fort Worth, TX) was covered by US Food and Drug Administration investigational device exemption #G020021. Written informed consent was obtained from all parents/guardians.