Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power: Randomized multicenter clinical study

Abstract

To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power. Twelve study centers in the United States. This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed. Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs. Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.