Original articleThe AcrySof Toric Intraocular Lens in Subjects with Cataracts and Corneal Astigmatism: A Randomized, Subject-Masked, Parallel-Group, 1-Year Study
Section snippets
Subjects and Methods
The study was conducted at 11 sites in the United States. Central or local institutional review boards approved the protocol before study commencement at each site. Subjects were counseled and provided informed consent before participating. Study conduct adhered to local and regional regulations, good clinical practices, the tenets of the Declaration of Helsinki, and the Health Insurance Portability and Accountability Act.
Subject Disposition and Demographics
Of 541 enrolled subjects, 24 did not receive implants owing to preoperative or intraoperative exclusions; 517 received the AcrySof Toric IOL (n = 256) or the control IOL (n = 261). Results exclude subjects who received IOLs but discontinued (AcrySof Toric IOL, n = 4; control IOL, n = 2) or were lost to follow-up (AcrySof Toric IOL, n = 9; control IOL, n = 22). Subject gender was 44.9% male (232/517) and 55.1% female (285/517). Most subjects were white (96.7%, n = 500), followed by black (1.7%,
Discussion
Key findings in this study were favorable UCDVA, IOL stability, and spectacle independence demonstrated by the AcrySof Toric IOL. The low incidence of IOL rotation ≥15° (1.2%) with the AcrySof Toric IOL is a substantial improvement compared with the IOL rotation incidence of 16% to 50% observed in first-generation toric IOLs.18, 28, 29, 30 The favorable visual outcomes observed in this study were consistent with 2 generally accepted concepts: First, that rotational stability is essential for
Acknowledgments
In addition to the authors, Brad Black, MD, Warren Hill, MD, Douglas Koch, MD, Louis Nichamin, MD, and John Wood, MD were clinical investigators. Medical writing assistance, including preparation of the draft for author editing, was provided by Jeannette Tomanka, MS, NP-C, ELS, Alcon Laboratories, Inc.
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Manuscript no. 2009-1276.
Financial Disclosure(s): The authors have made the following disclosures:
Edward Holland – Consultant – Alcon Laboratories, Inc.
Stephen Lane – Consultant, Lecture Fees – Alcon Laboratories, Inc.; Consultant, Lecture Fees – Bausch & Lomb Inc.; Consultant – Visiogen
Jeffrey D. Horn – Consultant, Lecture Fees – Alcon Laboratories, Inc.
Paul Ernest – Consultant – Alcon Laboratories, Inc.
Robert Arleo – Consultant, Financial Support – Alcon Laboratories, Inc.
Kevin M. Miller – Financial Support – Alcon Laboratories, Inc.
Sponsored by Alcon Laboratories, Inc., Fort Worth, Texas.
Dr. Holland is Director, Cornea Services at the Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. Drs. Holland, Lane, Horn, and Arleo are consultants for Alcon Laboratories, Inc. Dr. Lane is a medical monitor for Alcon Laboratories, Inc. Dr. Miller has received payment as a clinical investigator for Alcon Laboratories, Inc.