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Up Front | Jan 2003

Update on the AcrySof

Results of the multicenter study of the AcrySof Multifocal IOL


Alcon Laboratories, Inc. (Fort Worth, TX), has developed an acrylic diffractive multifocal IOL that is 13.0 mm in overall length and has a 6.0-mm diameter optic. The new MA60D3 model, which is under current clinical investigation, is a three-piece design with PMMA haptics. The lens, which features an anterior diffractive surface, has a 3.6-mm graduated diffractive gradient. This new design differs from the original 3M (St. Paul, MN) diffractive design in that only the central 3.6-mm radius has the defractive gradient and this gradient is graduated. The latter effect is achieved through a process known as apodization, which creates a controlled reduction in the defractive step height from the center of the radius to the periphery. This effect provides a gradual energy blend between the distance focus and near focus, and improves near-vision contrast, as well as distance vision, for larger pupils.

Simultaneous Visual Function
The MA60D3 is a simultaneous vision lens, which enables the patient to see both a focused image and defocused light from a second image. It emphasizes excellent distance vision with large pupils and produces minimal nighttime photic phenomena. There is approximately equal distance and near vision in average-to-small pupils. This improvement in the quality of distance vision and the absence of photic phenomena are due to both the reduced diameter of the lens' diffractive region and its graduated diffractive steps. This shift toward distance as opposed to near vision becomes apparent at approximately 3.0 mm of pupil size, at which point the distance vision takes priority over the near vision and increases as the pupil dilates up to 6.0 mm. As the pupil size grows, the lens becomes heavily distance-oriented.

Study Objectives
The objectives of the current multifocal IOL study are to demonstrate safety and effectiveness, as well as to compare the results to our conventional results with a monofocal AcrySof IOL (Alcon Laboratories, Inc.). The study is to include 300 subjects implanted bilaterally with the defractive multifocal design, the results of which will be compared to those of 200 subjects who will receive the standard monofocal design. The study will include the usual data analysis of UCVA and BCVA at both distance and near, as well as near visual acuity with best distance-corrected vision in place, low contrast acuity, glare, visual acuity, and depth of focus. The study will also ask patients to fill out a subjective questionnaire regarding their quality of vision.

Early Results
The 30- to 60-day interval of the MA60D3 study revealed very little difference between the uncorrected vision of the multifocal lens as compared with the monofocal lens, and both groups showed excellent uncorrected distance vision (Figure 1). The patients' UCVA was approximately 0.5 lines less with the multifocal IOL compared with the monofocal IOL, with a mean distance visual acuity of 20/32 and 20/25, respectively. The multifocal patients experienced a significant improvement in mean near vision, however, compared with the monofocal group, with approximately 20/32 and 20/100, respectively. With the distance vision in place, the near vision in the multifocal group was approximately 20/25 compared with 20/80 at near in the monofocal group.

One of the most important findings to come out of this study was that, when surveyed at 60 days, on a scale of zero to seven (zero meaning not observed and seven meaning incapacitated), there was no significant difference between the observations of the patients in the multifocal group compared with the monofocal group in regard to glare flare, nighttime vision problems, or halos. Additionally, the patients in the multifocal lens group fared more favorably with regard to distorted and blurred near vision.

Status
Currently, over 200 multifocal patients and 100 mon-ofocal patients are been enrolled in the study, and the data analysis is ongoing. I feel that the AcrySof MA60D3 multifocal IOL provides good distance vision and excellent quality night vision. It shows clinically insignificant photic problems as compared with the monofocal control while at the same time providing mean near visual acuity of approximately 20/30.

Stephen F. Brint, MD, FACS, is Associate Clinical Professor of Ophthalmology at Tulane University Medical School in New Orleans. Dr. Brint is a consultant for Alcon Surgical. He may be reached at (970) 920-3315; brintmd@aol.com.

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