The +3.0-D add version of the apodized diffractive multifocal IOL provides a high rate of spectacle independence.
Dr. Mackool reviewed the results from the FDA multicenter study comparing the ReSTOR +3.0 and ReSTOR +4.0 (SN6AD3) multifocal IOLs and presented the outcomes achieved in the first 30 patients in whom he bilaterally implanted the ReSTOR +3.0 after it became commercially available.
In the FDA study, 96% of patients with the ReSTOR +3.0 implanted were satisfied with the outcome of their surgery even though only 76% achieved spectacle independence. However, the latter result must be considered against the restrictions of the study protocol that prohibited any intraoperative or postoperative enhancements to correct astigmatism or residual spherical refractive error. The impact of this limitation is highlighted by the results from Dr. Mackool's clinical series where all patients were spectacle-independent at 3 months after surgery.
The FDA study was conducted at 22 sites and included 269 patients who were randomly assigned to bilateral implantation of the +3.0-D or +4.0-D add versions of the multifocal IOL. The functional results showed no difference between the groups in distance uncorrected visual acuity (UCVA).
In near acuity testing with distance correction, the preferred reading distance was 3 inches farther for patients who received the ReSTOR +3.0 compared with the ReSTOR +4.0 (15 inches versus 12 inches). Consistent with that finding, patients in the ReSTOR +4.0 group could read print with a 20% smaller font, he said.
Results of intermediate vision testing performed at 20, 24, and 28 inches showed the ReSTOR +3.0 group outperformed the ReSTOR +4.0 group at all distances.
"The differences between the two groups were tremendous, with the proportions of patients able to achieve 20/32 or better intermediate UCVA being at least twofold greater in the ReSTOR +3.0 versus +4.0 group," he said.
The differences favoring the +3.0 lens also were demonstrated in the defocus curve that showed mean visual acuity averaged 1.5 lines better for patients with the ReSTOR +3.0 implanted compared with the ReSTOR +4.0 cohort across the distance range from 14 to 40 inches. At 24 inches, vision was better by about 2.5 lines for the ReSTOR +3.0 group.
"At distances closer than 14 inches, the ReSTOR +4.0 D multifocal IOL provided better vision than the ReSTOR +3.0," Dr. Mackool said. "However, excluding certain subgroups of individuals with demands for extremely near vision, the majority of people do not care about good uncorrected acuity at such a close range."
There was no difference between the two models in the incidence of severe glare and halos, which occurred at a rate of about 5%.
In Dr. Mackool's series, all patients were seen at 3 months after surgery and most had follow-up to 6 months. The patients had no pre-existing disease that might compromise their visual outcome and were targeted for a plano refractive result. About half of the patients had intraoperative limbal relaxing incisions, which were performed to treat pre-existing astigmatism of 0.5 to 1.5 D.