Elsevier

Ophthalmology

Volume 117, Issue 11, November 2010, Pages 2104-2111
Ophthalmology

Original article
The AcrySof Toric Intraocular Lens in Subjects with Cataracts and Corneal Astigmatism: A Randomized, Subject-Masked, Parallel-Group, 1-Year Study

Presented in part at: the American Society of Cataract and Refractive Surgery Symposium, April 2007, San Diego, California.
https://doi.org/10.1016/j.ophtha.2010.07.033Get rights and content

Purpose

To compare the AcrySof Toric intraocular lens (IOL) and an AcrySof spherical control IOL and to investigate rotational stability of the AcrySof Toric IOL (Alcon Laboratories, Inc., Fort Worth, TX) in subjects with cataracts and preexisting corneal astigmatism.

Design

Randomized, subject-masked, parallel-group, multicenter, 1-year study.

Participants

We included 517 subjects (Toric IOL, n = 256; control IOL, n = 261).

Methods

Unilateral implantation of an AcrySof Toric or AcrySof spherical control IOL (spherical powers, 12.00–25.00 diopters [D]; cylinder powers 1.50, 2.25, or 3.00 D for corneal astigmatism correction of 0.75 to <1.50, ≥1.50 to <2.00, and ≥2.00 D with no upper limit, respectively). No limbal relaxing incisions were permitted.

Main Outcome Measures

Visual acuity outcomes, IOL position, patient-reported spectacle use, and safety.

Results

One year postoperatively, best spectacle-corrected distance visual acuity of ≥20/20 was 77.7% (Toric IOL) versus 69.2% (control IOL). Uncorrected distance visual acuity of 20/20 or better was 40.7% (Toric IOL) versus 19.4% (control IOL; P<0.05). Mean absolute residual refractive cylinder was 0.59 D (Toric IOL) versus 1.22 D (control IOL; P<0.0001). Mean rotation was <4° (range, 0°–20°) for the Toric IOL. Six-month spectacle freedom was 61.0% (Toric IOL) and 36.4% (control IOL; P<0.0001). Complications in both groups were few and were as would be expected with cataract surgery.

Conclusions

Favorable efficacy, rotational stability, distance vision spectacle freedom, and safety results support the use of the AcrySof Toric IOL for patients with cataracts and corneal astigmatism.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

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.

References (34)

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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.

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