The Acrysof Restor IOL (Alcon Laboratories, Inc., Fort Worth, TX) (Figure 1) received FDA approval in March 2005. Using unique apodized diffractive and refractive technology, this multifocal lens is designed to provide excellent distance and reading vision. In addition, patients' intermediate vision at 50 to 70cm is quite good, and the vast majority of subjects who underwent implantation of this lens in the FDA study achieved complete independence from their spectacles.
The optical function of an apodized optic is gradually modified from the center of the lens to its edge. This technology is used in microscopy and astronomy in order to improve image quality. The central 3.6mm of the Restor is apodized with diffractive steps that gradually decrease from 1.3 to 0.2µm in height. The performance of the lens is similar regardless of pupil size, so candidates for implantation are not limited by the diameter of their pupil. Because the lens provides a wide range of high-quality vision, most patients obtain a UCVA of 20/40 or better at near, intermediate, and distance.
FDA STUDY RESULTS
In the FDA study, 465 patients underwent bilateral IOL implantation, with 340 patients receiving the multipiece (MA60D3) and 125 receiving the single-piece (SA60D3) design. Both the Restor and the control group achieved excellent uncorrected distance acuity. The Restor patients, however, had dramatically superior near vision when compared to the control group.
Specifically, 82.4% of the Restor patients attained an uncorrected distance acuity of 20/25 and a near acuity of J2 (20/32) or better compared with 22.7% of the controls. When corrected for distance, 92.4% of the study patients and 15.9% of the controls achieved these levels of acuity. Intermediate acuity at 50, 60, and 70cm was 20/40 or better in 82.4%, 85.3%, and 67.6% of Restor patients, respectively.
There were no clinically significant differences in either photopic or mesopic contrast sensitivity tests between the Restor and control subjects. The incidence of severe night vision problems (glare and halos) was approximately 5% in Restor patients and 1% to 2% in the monofocal control group. The problem did not appear to be related to postoperative pupil size, IOL power, or corneal topographic features. Surgeons implanting the Restor IOL should therefore inform all patients preoperatively that they may have nighttime visual problems after surgery. Patients should understand that, in such instances, it may be necessary to replace the multifocal with a monofocal lens.
The results of the FDA study indicate that the Acrysof Restor IOL provides excellent vision at distance and near and very good intermediate acuity. Eighty percent of study subjects reported never using spectacles after the bilateral implantation of this multifocal lens, and an additional 17% reported that they sometimes used glasses (Figure 2). Overall patient satisfaction was high, with greater than 93% of study patients indicating that they would again undergo implantation of this lens.
Richard J. Mackool, MD, is Director of the Mackool Eye Institute and Laser Center in Astoria, New York. He is a consultant to Alcon Laboratories, Inc., but states that he holds no financial interest in the products mentioned herein. Dr. Mackool may be reached at (718) 728-3400 ext. 256; email@example.com.